查看完整版本: 思比易临床有效性资料汇总(如要辩论,请另开新帖)

思比易临床有效性资料汇总(如要辩论,请另开新帖)

[quote]原文由 [B]小楼听春雨[/B] 发表:
每个人都有发表自己言论的权利,不同意别人的观点,可以辨论, 但严禁谩骂,严禁对他人进行人身攻击。
口吃辩论的范围限于口吃的各种理论和方法。实事求是、言之有理、证据确凿地发表各自观点与看法。
……
［此帖子已被 小楼听春雨 在 2006-10-18 10:29:28 编辑过］
[/quote]

[SIZE="2"]事实上，关于思比易思比易临床有效性，已经有一些资料散见于中国口吃社区。本人声明：

1）、支持小楼公告中的发言，但希望“说到做到，一视同仁”。但是在口吃社区中，关于思比易的问题，正如愚公所说，“面对社区一小撮人对思比易的恶意攻击, 如: 侮辱思比易注册商标, 毫无理由的攻击思比易价位高, 攻击思比易的广告是虚假夸大的……”，而针对思比易的工作原理、使用效果等核心问题，除了漫骂攻击、无中生有、捏造事实、或者无知臆测外，几乎没有发现实质性的反驳意见和证据。举个例子，在社区研究论坛里，应自然的要求，以德服人曾经发过以下2个帖子，请大家有时间翻开看一下，自行评论。
[原创]DAF（听觉延迟反馈）对口吃矫正无效性的探讨 (  1 2 )
[分享]国内公开发表的2篇关于口吃矫正器的临床研究文章

2）、关于辩论的问题。赞赏童镭的看法：“对同一件事物的看法不一致，当然就会有争论，有争论就会有乱的现象。但是，造成“混乱”的并不是争论本身，而是引发争论的问题。而这个问题本身才是我们需要真正关注的！”。我们看口吃社区是怎么争论的，举几个例子，只要有人对思比易表示支持或好感，不管是真正的用户还是真的思比易工作人员，就一定被某些人扣上是思比易工作人员或托儿的帽子；在相当数量的思比易满意度调查、公开的论文/文献，包括3个口吃者佩带思比易前后的对比视频见诸社区之后，仍然有人在没有事实依据地、不断的重复宣称思比易无效论，而这些人恰恰不是思比易的用户。当然，作为真正的思比易用户的正当维权行为，包括在社区投诉、向企业投诉、甚至法律维权都是应该支持的，在此过程中即使言辞过激也是可以理解的。下面的2个帖子出现口吃社区辩论争鸣中，请大家看看祖栋和SpeechEasy是怎样进行正常辩论的，再看看某些人是怎样在里面胡搅蛮缠的，人品的高下一看便知。
与「SpeechEasy」进行对[思比易]的交流、探讨(1) (  1 2 )
与「SpeechEasy」进行对[思比易]的交流、探讨(2) (  1 2 )

3）、在本主题帖中，我将把一些思比易有效性的资料陆续传上来，为保证资料的完整性，希望各位吃友不要在本帖中进行辩论，但鼓励大家摘录其中的有关内容另开新帖进行实事求是的辩论，共同提高。

4）、鉴于相当一部分资料是国外公开发表论文的扫描版/PDF版，有些篇幅很长，同时有大量的图表，我会尽可能翻译一些摘要内容（全文翻译太费时），一些图表可能无法上传或格式发生一些变化，请大家谅解。

5）、鉴于目前口吃社区的状况（我注意到在社区的研究论坛，即使是公开文献，只要提到思比易，也会被删除），因此本人没有将其发布到中国口吃社区，但还是欢迎吃友转帖，同时谢谢口吃基金会的平台，也向童镭和愚公致敬！！！[/SIZE]

前言：

陆续上传思比易有效性资料包括：国内外实例；国内外文献；顾客满意度调查。

为避免误解，首先说明：

1）、思比易是“口吃矫正器”，而不是“口吃治疗仪”；思比易从来没有宣称过可以治疗口吃，更不用说治愈口吃；但不排除个别案例在使用一段时间后，可能出现摆脱对仪器依赖的情况；
2）、思比易并不会对所有口吃者都有效，国内外的统计数据表明，其有效率在75%—85%之间，正是基于此，其生产方才要求其下属所有业务人员和代理商必须遵守“免费试戴、免费咨询、用户自己作出购买决策”的基本原则。


一、口吃者使用思比易前后对比的视频（国内口吃者）


[url]http://www.micro-dsp.com/service/clientinformation.htm[/url]

黄小姐试戴思比易视频
蒋先生试戴思比易视频
尤小姐试戴思比易视频

简要说明：

其中有一位是口吃社区会员，但目前已经不敢在社区露面了。漫骂和攻击没有哪个吃友受得了！！！

二、口吃者使用思比易的媒体报导和实例节选（国外口吃者）

1）、2002年8月24日CCTV新闻频道以“新发明帮助口吃者重拾希望”为题的报导；

[url]http://www.micro-dsp.com/news/addtionfile/cctvwebreport_2.mht[/url]

2）、美国最大的报纸《今日美国》（《USA Today》）关于思比易的报道

[url]http://www.micro-dsp.com/news/addtionfile/Thosewhostutterfindhope.mht[/url]

3）、美国著名媒体《早安美国》再次报道思比易

[url]http://www.micro-dsp.com/news/addtionfile/DeviceHelpsWomanOvercomeStutter.mht[/url]

中文摘要翻译如下：继2002年8月《早安美国》以“stop stuttering（停止口吃）”为题报道思比易后，在美引起巨大反响，并获得该年度媒体报道三个催人泪下的故事之一。事隔两年后，今年1月21日，该媒体发表了《帮助女青年克服口吃的神奇仪器》的署名文章。讲述了又一思比易的受益者－麦迪.考利斯在经历了26年口吃折磨后，参加了在美举行“超越自己”捐赠活动，获赠思比易，并终于成功克服了口吃的故事。 “思比易使我重获新生。我将重返学校，立志成为一名专门帮助问题儿童的健康顾问”是考利斯重获人生目标的感言。


4）、2006年7月17日，英国Telegraph以“现在没有什么能阻止我正常说话”（“Now I can speak, there's no stopping me”）为题的报导

[url]http://www.telegraph.co.uk/health/main.jhtml?xml=/health/2006/07/17/hheidi17.xml[/url]

中文摘要翻译如下：
金海蒂（Heidi King），从3岁起开始出现恼人的口吃，就是那种她讲话时，你都不知道该往哪儿看的情形：每说出一句话都像是经过一番斗争，每个单词就像是她嘴里的石头，使她说话时整个面部都扭曲了。
今年，在她25岁时，海蒂第一次找到了自己的声音。6月，海蒂在美国言语病理学家的指导下，选配了Speecheasy 思比易口吃矫正器，一个月后，海蒂完全变了个人：更精神，更自信，说话时面部表情也不在那么紧张。SpeechEasy思比易根据在合声说话/合唱情况下口吃会减轻的原理，利用数字听觉反馈处理技术，使口吃患者的说话变得流利。经过言语评估，海蒂在佩戴思比易之前，35.4%的单词会出现口吃，每分钟只能说出89个单词，而佩戴之后，只有4.4%的单词会出现口吃，每分钟能说出173个单词。    用海蒂自己的话来讲：现在，我终于可以控制自己的说话，语速也能跟上我的思考了，我能说话，没有什么可以阻止我。

简要说明：

1）、以上是部分节选内容。对于国外的正规媒体与国内一些媒体，二者有相当区别，我理解为简单一句话，国外媒体更注重客观性和真实性，其次才是新闻性，在这种情况下，花钱未必能够办成事。（我并不是贬低国内媒体，这需要法制环境和发展时间）
2）、国外NBC电视台和Opera等的电视报导，由于太大和网站的原因无法上传，请谅解。如吃友需要，可与微迪公司相关人员联系。

三、美国东卡罗尼娜大学沟通与传播失调系2003年8月22日公开发表的论文
论文原始信息：
INT. J. LANG. COMM. DIS., 2003, VOL. 38, NO. 00, 1–21
《HealthSciences》
标题：Investigations of the impact of altered auditory feedback in-the-ear devices on the speech of people who stutter: initial fitting and 4-month follow-up
作者：
Andrew Stuart, Joseph Kalinowski, Michael P. Rastatter,
Tim Saltuklaroglu and Vikram Dayalu
Department of Communication Sciences and Disorders, East Carolina
University, Greenville, NC, USA
日期：
(Received 13 May 2003; accepted 22 August 2003)


论文摘要翻译：

关于改变听觉反馈原理在耳内式口吃矫正器上的应用效果跟踪调查（分别在初始验配时和使用四个月后）

作者： Andrew Stuart, Joseph Kalinowski, Michael P. Rastatter, Tim Saltuklaroglu and Vikram Dayalu
Department of Communication Sciences and Disorders, East Carolina
University, Greenville, NC, USA
(Received 13 May 2003; accepted 22 August 2003)


摘要

背景资料： 关于改变听觉反馈原理在耳内式口吃矫正器上的研究应用是在近一段时间才真正被关注的。
目标： 本篇论文介绍了判定这种治疗口吃的耳内式产品的功效的三项实验。 产品的效果最终把患者初始佩戴产品和佩戴四月后说话中出现口吃现象的音节数量和比例以及言语的流畅度作为判定标准。
方法和步骤：
实验1：让2名青少年和4名成人分别在佩戴思比易前后的情况下， 阅读一段文章或者自己描述一件事情来测定改变听觉反馈原理在思比易上的应用是否足够有效。
实验2：根据以下特点将这些患者分成两组：
患者的年龄、佩戴产品的时间长短（初始佩戴或已使用四月后）、练习的内容（阅读或自己描述一件事）以及佩戴产品的状态（未使用或使用中）， 从而比较出他们出现口吃现象的比率差异。
实验3： 通过实验2的测试结果， 比较患者在初始佩戴思比易和使用四月后的效果。
结论： 以上实验结论进一步肯定了改变听觉反馈原理在耳内式口吃矫正器的应用效果。 只要使用了这项产品， 患者的口吃出现频率就会降低，而言语自然度较未佩戴时更佳。
介绍
事实上， 运用改变听觉反馈原理治疗口吃已有45年的历史。 改变听觉反馈原理又与未改变听觉反馈原理有联系（因为后者所涵盖的两个分支：听觉延迟反馈以及频响改变反馈）。根据实验证明， 掩蔽改变反馈原理在减少口吃的有效性上不如听觉延迟反馈以及频响改变反馈突出。但这种单一被动接收声音信号的机械产品本身会产生AAF效应， 而导致了低下的治疗效果， 因此，运用AAF技术抑制口吃的方法至今没有得到业内认可。 同时， 随着DAF和FAF的原理在治疗口吃方面的成功案例和研究报告逐渐增多， 它们的科学性也逐渐被关注和认可。 但因初期开发的相关产品都外型笨重，不易患者携带，因此最终没有成功投放市场。 思比易却是一项带有这项技术，且外形轻巧，秘密置于人体耳内的口吃矫正产品。 自2000年起， 关于它功效的调查试验报告就陆续在相关刊物上发表， 证明了它在口吃治疗方面的强大功效。

另一项实验的主要方法，是邀请8名带有中重度口吃障碍的患者（4名成人，4名儿童）通过一些方法测定出他们的口吃严重度。 然后根据每人不同的特点，为他们定做了不同的思比易。 （儿童佩戴耳道式，成人佩戴完全耳内式）。 在他们练习思比易治疗口吃方案以前，通过观察他们阅读和对话测出他们的各项口吃参数， 作为接下来实验结果的参照标准。 在这些参与者带上思比易后，我们还对他们就如何正确使用思比易和达到最佳言语流畅度的相关技巧进行了30分钟的教授培训。

在他们八人佩戴思比易四个月后，我们邀请他们重新参与思比易的功效实验。

结论

我们通过同样的方式比较他们佩戴思比易前后的口吃严重度。 搜集了他们阅读或谈话中的300个音节，并且确定了口吃的定义是出现单词重复、说同一单词时间超长等的现象。

最后通过各项测试方法， 得出患者使用思比易四月后的效果与刚佩戴时完全一样！在使用思比易的过程中，患者的口吃出现频率不会出现大的增长。 可以肯定思比易为广大口吃人群提供了快捷高效的治疗口吃的解决办法。

简要说明：

1）、该论文原文长达22页，以上中文部分仅为摘要翻译；

2）、大量图表无法整理和上传。

（未完待续）

四、美国东卡罗尼娜大学沟通与传播失调系专家2003年11月15日在美国芝加哥ASHA会议上公开宣读的题为《思比易治疗方案一年使用跟踪调查报告》的论文（入选会议论文汇编）

英文原文：

标题：
One Year Follow-up on People Who Stutter Using the SpeechEasy Treatment Protocol

作者：
Tim Saltuklaroglu, M-SLP; Vikram Dayalu, M.S.; Vijaya Guntupalli, M.S.; Joseph Kalinowski,
Ph.D.; Andrew Stuart, Ph.D.; Michael P Rastatter, Ph.D.
East Carolina University, Department of Communication Science Disorders

出处：
As presented in Poster #32 at the 2003 ASHA Convention in Chicago, IL, November 15th, 10:30– 12:00.

摘要
Abstract
After 1 year of using the SpeechEasy protocol for managing stuttering, 8 participants were re-examined on measures of stuttering frequency as well as on self-reported measures regarding speech attitudes and perceived improvement in speech when using the SpeechEasy protocol. Stuttering frequencies were measured on reading and conversational tasks with and without the use of the SpeechEasy device. Significant reductions in stuttering were noted on both tasks when the device was in place. These reductions were substantiated by self report data, which addressed 6 parameters of stuttering. Furthermore, all participants scored significantly lower on the three scales of the Perceptions of Stuttering Inventory after beginning to use the treatment protocol. These data suggest that the SpeechEasy protocol is proving to be an efficient and effective tool for managing stuttering.

Introduction
The SpeechEasy device had been available since July 2001, as an alternative or adjunct to traditional methods of treating stuttering. This device provides combinations of delayed auditory feedback (DAF) and frequency altered feedback (FAF). Both of these effects have a well-documented history of immediately and effectively reducing stuttering with minimal training. They are thought to be derivatives of choral speech, which is widely accepted to be the most potent inhibitor of stuttering
The SpeechEasy protocol differs from traditional methods of treating stuttering as the training is short (approximately 3 hours) and consists of only minor motoric changes to help highlight and draw attention to the auditory signal. However, for a treatment of stuttering to be considered effective, the immediate reductions in stuttering should also be visible over the long term. Furthermore, participants should also notice the difference in settings that extend beyond the clinic. As such, their ratings across various parameters of stuttering such as those found on the Perceptions of Stuttering Inventory (PSI), and their self-ratings of the SpeechEasy device should reflect the clinical measure of reductions in stuttering frequency.

Materials & Methods
Participants: 8 subjects (7 male, 1 female) aged 9-51, who had been using the SpeechEasy device for approximately 1 year.
Testing:
o Frequency counts of stuttered syllables, both with and without using the SpeechEasy device, in both reading and conversation tasks.
o Perceptions of Stuttering Inventory (Wolf, 1987) comparing self-reports of avoidance expectancy and struggle before acquiring the SpeechEasy and after using it for a year.
o Self-Reported Efficacy Questionnaire comparing stuttering parameters before acquiring the SpeechEasy and after using it for a year.
Discussion and Conclusions
Frequency Counts
A (3x2x2) repeated measure ANOVA was conducted to examine the effects of time, task and device on stuttering frequency. The only statistically significant event was the presence of the device (p < 0.01). Time (initial, 4-month, or year) and Task (conversation or reading) showed non-significant effects (p = .421 and p= .277) respectively. No significant interactions between effects were detected.
Therefore, the reduction in stuttering events seems to be stable over time. However, stuttering continues to manifest normally when the device is removed. Perceptions of Stuttering Inventory (PSI)
Self-reported measures of struggle, avoidance and expectancy associated with stuttering were significantly reduced (p < .01) after the SpeechEasy and after using it for a year.
Self-Reported Efficacy Scale
This scale provided self-report data on a 7-point scale that assessed the following parameters before and after beginning to use the SpeechEasy protocol:
o Overall stuttering frequency.
o Use of avoidances.
o Speech naturalness.
o Frequency of telephone usage.
o Stuttering on the telephone.
o Stuttering in conversation.
Improvements were significant on all scales (p < .01), reflecting measures of frequency counts and the PSI. Furthermore, the mean satisfaction rating given to the device was 1.75 on the 7 point scale, indicative of high levels of satisfaction.
Speech Naturalness
Speech naturalness has not yet been analyzed. However, considering the speech at the initial and 4-month periods was perceived as being highly natural, and few motoric changes were necessary to achieve these results, we anticipate positive naturalness judgments of these data.
Conclusions
These data indicate that the SpeechEasy protocol, which requires minimal training of the user, is continuing to provide effective management of overt and covert stuttering symptoms after one year of use. The effects after 1-year appear to be similar to those achieved at the initial contact and 4-month testing period.
These devices are intended to inhibit stuttering in the same manner as choral speech. Though the stuttering inhibition is not equal to that achieved by choral speech, the results are promising for a first generation device. Future models are expected to provide better emulations of choral speech.
Results（（6张图片无法上传）

智在沟通说明：
以上英文原文根据PDF文件转化，个别地方格式可能需要调整。

中文摘要翻译：

标题：

思比易治疗方案一年使用跟踪调查报告

作者：
Tim Saltuklaroglu, M-SLP; Vikram Dayalu, M.S.; Vijaya Guntupalli, M.S.; Joseph Kalinowski, Ph.D.; Andrew Stuart, Ph.D.; Michael P Rastatter, Ph.D.
East Carolina University, Department of Communication Science Disorders
出处：
As presented in Poster #32 at the 2003 ASHA Convention in Chicago, IL, November 15th, 10:30– 12:00.

作为一项替代传统口吃治疗设备的创新性产品，思比易®于2001年面世，它通过结合听觉延迟反馈和频率改变反馈从根本上抑制口吃。 所有的工作原理都以国际上最新的研究成果和理论为依据，使用者只需通过简单的培训后就可使用自如。思比易®是在“合唱效应”原理上派生并研发出的，目前被外界广泛认可为治疗口吃的新一代产品。
思比易®治疗方案由于花费的培训时间短（约3小时）而区别于传统方法，使用者只需要更多关注外界声音信号。它几乎不会造成使用者言语行为的特别变化。
另外，为达到最佳治疗效果， 使用者应该长期掌握自身使用效果的情况，也可关注由于环境的改变（离开验配店后）而对验配参数重新设置的需求情况，从而得出各项验配参数的级别变化，评估长期使用产品的效果如何。

实验案例&方法

参与者： 8名（7男1女），年龄在9-51岁之间， 已经使用思比易®达一年以上。

测试方法：

1. 通过试验者阅读一段材料及情景对话中出现语阻现象的频率，来比较他们佩戴思比易®的前后效果。
2. 通过观察试验者出现回避难发字的频率， 来比较他们使用思比易®前和使用一年后的差别。
3. 从试验者反馈的功效调查表中， 比较口吃参数的前后变化。

调查结论

通过实验表明，思比易®在减轻口吃现象，提高说话流畅程度上具有良好的效果（有效率80~90%），在说话的自然程度和使用方面上比传统的口吃矫正方法和器械具有更大的优势。到目前为止，思比易®的长期效果的临床实还在进行，其中最长的达3年。

（图示部分略）。

（未完待续）

思比易国际认证：
中国 医疗器械生产许可证编号：[川 药管械生产许（2004）第0001号(更)]
中国 医疗器械注册编号：[川食药监械（准）字2005第2550011号]
欧盟CE注册号：[HD 60009248 0001]
EN ISO13485证书编号：[SX 60009249 0001]
加拿大CAN/CSA-ISO13485证书编号：[745002540]
美国FDA注册号：[3005060451]

[B][SIZE="6"][CENTER]思比易（SpeechEasy）口吃矫正器矫治口吃临床观察[/CENTER][/SIZE][/B]

[CENTER]杨利1 蒋涛2 黎万荣 王玉冰 钱利[/CENTER]

摘要：目的 观察思比易（SpeechEasy）口吃矫正器对口吃矫治的疗效。方法 让5名口吃患者使用口吃矫正器，记录受试者治疗前后正常语速下每100个音节中出现口吃的音节数，并统计结果。结果 经使用口吃矫正器，受试者口吃音节百分比均下降，有效率达77.1％(p〈0.01〉。结论 思比易（SpeechEasy）口吃矫正器能有效地矫治口吃。

关键词：思比易口吃矫正器，矫治，口吃

[CENTER]A  Clinical Study on the effectiveness of SpeechEasy on reducing stuttering

Yang li, Jiang tao, Li Wanrong, Wang Yubing, Qian li

Departemnt of Otolaryngology,  Luzhou Medical College Hosiptal Sichuan  
Luzhou 646000[/CENTER]

ABSTRACT:  Objiective To study the effectiveness of SpeechEasy on reducing stuttering in patients. Methods Select 5 stuttering patients and fit them with SpeechEasy devices. Then examine the change of number of stutting syllable for each word. Record the numbers of stuttering in 100 words before and after using SpeechEasy. Results the numbers of stuttering syllables in 100 words significantly decreased as a result of comparison. The reduction of stuttering in this measure was 77.1％.This indicates a statistically difference between the two conditions. Conclusion SpeechEasy can improve fluency effectively if used correctly.

keywords: SpeechEasy, stuttering

      口吃疾病，俗称“结巴”，是一种直接影响人的交流、多因性的言语障碍症。口吃易发于幼童时期，5％到15％的儿童可能在其发育期发现口吃.到了高中后，口吃发病率降到1％左右. 进入成年后，口吃发病率基本保持在1％. 就性别而言，3岁前，患口吃疾病的男女儿童各半，到一年级时，男女儿童比例变成3:1，而患口吃疾病的成年男女性别上升为4:1，即大部分口吃患者为男性[i]。一般来说口吃症状随着年龄的增长逐渐加重，并直接妨碍患者与他人交流，造成其学习、沟通能力下降，严重影响患者的生活和工作。目前，世界上有6千万口吃患者，美国有近3百万患者。虽然，中国还没有关于口吃疾病的大规模流行病学调查，如按此国际通用的口吃发病率降推算，中国至少有1000万患者。

    至今，口吃的病因仍不清楚，争议较大。但是，对于引起口吃的一些重要因素学术界已有共识，其中包括基因、神经生理、儿童发育、心理等。从20世纪初期开始，神经生理学说逐渐成为解释口吃疾病病因的主要理论。这种理论认为口吃疾病是由于大脑的左、右半球交流不畅引起的。

    从医学上讲，目前尚无有效的常规药物和手术治愈口吃疾病。临床上仍使用以心理引导、言语语言训练等为主的传统方法。今年来在国外，开始使用不同的口吃矫正器械，如利用噪音掩蔽、声反馈（DAF）等技术来抑制或减轻口吃。不过，长期以来，这些矫正方法没有突出的效果，因此，缓解口吃症状并研制出有效的治疗手段一直是临床言语病理学家和耳鼻喉科医生努力不懈的目的。

    听觉延迟反馈可以直接、强有力地改善大脑左、右半球的交流状态，促进言语流利程度。早期临床试验结果表明应用听觉延迟反馈，患者口吃症状可完全消失。当然，根据口吃症状轻重不一，听觉延迟反馈的治疗效果也不一样。研究结果证明使用听觉延迟反馈治疗口吃的成功率（80％－90％）大于其它类似的方法，如噪音掩蔽法（40％－50％）。加拿大的Armson博士领导的达尔豪斯大学大众传播失调研究生院和以Kalinowski教授为主的美国东卡来纳大学口吃研究实验室在这方面有独到的研究，是世界上研究口吃的主要基地。从90年代初期开始，他们共发表了近60篇专题研究沦文，在研究听觉延迟反馈和移频听觉反馈方面取得了重大成果。1993年，Kalinowski教授和Armson博士在《语言和言语》杂志上发表的题为《听觉反馈和语速变化对口吃频率的影响》论文被认为是当今引导研究听觉延迟反馈治疗口吃的重要文献。该文明确地提出调整听觉延迟反馈的时间可提高口吃治疗的效果，这对以后在研制治疗口吃器械上起到了重要作用。值得一提的是听觉延迟反馈不仅仅用于治疗口吃，同时已广泛用于治疗其它疾病，如帕金森症、失语症等。

    思比易（SpeechEasy）口吃矫正器由加拿大微迪数字技术公司研制出来，有三种式样：耳背式(BTE)，耳道式(ITC)和深耳道式(CIC)。均由外壳，麦克风、扬声器和数字信号处理DSP(digital signal processing)芯片，音量旋钮、电池仓、编程器接口等组成。延时和频移功能由数字信号处理芯片完成。其工作原理是让麦克风采集使用者的说话声音，所采集的语音信号通过特制的模/数转换器转为数字信号，再送到数字信号处理芯片。数字信号处理器在特制的算法控制下完成延时，频率变化，降噪处理，自动增益控制等各项技术处理，再经过数/模转换成语音信号，最终用扬声器输出到使用者耳内。

    从2001年起，思比易微型全数字口吃矫正器的临床试验分别在美国、加拿大、挪威和南非进行。其中一部分结果已陆续在学术杂志上发表，包括《美国生物工程年鉴杂志》、英国《残疾和康复》杂志、美国《言语、语言和听力研究》杂志、《国际语言交流失调》杂志等。2005年在加拿大言语语言病理学家和听力学家学会的年会上，加拿大达尔豪斯大学大众传播失调研究生院的奥康力等公布了他们对思比易微型全数字口吃矫正器的第一期试验结果，表明该口吃矫正器对患者有明显的治疗效果。第二期试验仍在进行。除了对口吃患者的治疗效果，国外学者开始将思比易微型全数字口吃矫正器用于其他言语语言疾病的治疗。2005年芝加哥来西大学医学中心的艾米丽.王博士发表了《使用思比易微型全数字口吃矫正器改善帕金森患者的言语清晰度》的论文，她和她的同事的研究表明思比易微型全数字口吃矫正器对帕金森患者也有重要的作用。到目前为止，全球已有近6000口吃患者在使用思比易微型全数字口吃矫正器，报道的治疗效果在50％～90％之间，与早期的实验结果基本吻合。

    鉴于目前几乎所有对思比易口吃矫正器的研究均在国外进行，为了验证是否对说汉语的中国口吃患者具有同样的疗效，我院听力语言疾病防治中心在2003年12月至2005年1月间，对5名口吃患者验配了思比易，并进行观察和随访，其试验结果报道如下。

1.资料与方法：

1.1  一般资料：五名患者中，男性3名，女性2名，年龄6-25岁，平均年龄16.6岁，5名患者均无发音器官畸形，无智力障碍，无听力障碍。

1.2  治疗方法：（1）检测五名患者在正常语速下每100个音节中出现口吃的音节数。（2）佩戴思比易口吃矫正器后，调整延时听觉反馈50—100 ms，移频听觉反馈范围为-1/2－+1/2 倍频。音量调到降低口吃效果最明显的位置，再次检测五名患者在正常语速下每100个音节中出现口吃的音节数，并统计结果。

2.结果：

2.1 治疗前后五名患者的口吃音节数占总音节数的百分比如下表：

        表1 治疗前后五名患者的口吃音节数占总音节数的百分比数

           患者         [COLOR="Lime"]治疗前(％) [/COLOR]              [COLOR="darkgreen"] 治疗后(％)[/COLOR]
                  1                 [COLOR="lime"] 32 [/COLOR]                          [COLOR="DarkGreen"]11[/COLOR]
                  2                [COLOR="lime"]42.5[/COLOR]                          [COLOR="darkgreen"]8[/COLOR]
                  3                   [COLOR="lime"]25[/COLOR]                          [COLOR="darkgreen"] 6.1[/COLOR]
                  4                   [COLOR="lime"]34[/COLOR]                           [COLOR="darkgreen"]7.8[/COLOR]
                  5                   [COLOR="lime"]38[/COLOR]                           [COLOR="darkgreen"] 6[/COLOR]

治疗后口吃音节数较治疗前明显减少,差异有显著性意义(t=9.04,p<0.01)。


2.2 治疗后五名患者的口吃治愈率分别为：65.6％、80.9％、76％、79.4％、84.2％、总有效率为77.1％。这与国外其它实验室的研究结果基本一致。

3.讨论：

    口吃是一种交际过程中的言语流畅性障碍，儿童在言语发育过程中会出现言语重复，拖音或停顿现象，并非口吃，多可自愈。临床诊断口吃必须有以下表现：部分词语重复和拖音较频繁；出现紧张与说话伴随努力，如肌肉震颤屏气、喘气、握拳、摇头等；有意避开某些易引口吃的词语和说话场合，逐渐发展为对说话感到困窘和害怕。口吃表现为发音器官肌肉的痉挛或强直，但其发音器官并无器质性的病变，而存在发音和构音方面的协调性障碍，存在大脑言语优势半球不典型化，缺乏与言语运动相对应的两半球之间的协调活动的结果。同时，有研究表明：口吃患者的听觉反馈可能较正常人延迟，当听觉反馈延迟时，正常人说话也会变得不流利。佩戴思比易口吃矫正器后，调整延时听觉反馈50—100 ms，移频听觉反馈范围为-1/2－+1/2 倍频程，听觉信号直接强有力地改善大脑的左右半球交流状态，促进言语的流利程度。在本组研究中口吃矫正治疗成功率达77.1％，较好解决了口吃。

    口吃患者普遍伴有心理障碍，通常缺乏足够使自己适应愉快的防御机制，具有抑郁，担心，紧张，神经质的特点。所以使用口吃矫正器时要注意外观隐蔽性，思比易（SpeechEasy）口吃矫正器体积很小，象助听器CIC一样，带上后不易被看见，减轻了患者的心理障碍，再辅以心理暗示治疗，治疗成功率有了提高。

    目前临床上常用的口吃矫正法如言语训练、心理治疗、生物反馈－松驰疗法、药物如氟哌啶醇等效果均不太好，远期复发率很高，其中言语训练是重点，它包括放慢语速，诱导发音，应用气流及形成说话的节律等，均是以降低语速为核心，而本组研究中使用思比易口吃矫正器后无须放慢语速就达到治疗效果，在语速正常时成功率达77.1％。同时，我们观察到思比易患者无需经过长时间的特殊训练和，也没必要进行有意识的口吃抑制，在佩戴思比易时，患者的言语不仅流畅，而且自然，放松。总之，思比易在现阶段的口吃治疗中疗效较好，其远期复发率还有待观察。

参考文献：

1.         黄海茵，黄铎香.口吃的国内外治疗与研究回顾.中国临床心理学杂志,1996,4(4):246-248.

2.         Boberg E,Webster WG: Stuttering:current status of theory and therapy.Can Fam Physician 1990;36:1156-1160.

3.         Zimmermann G. Stuttering: A disorder of movement. J Speech Hearing Res,1980,23:122-136.

4.        Lee BS. Artificial stuttering. J Speech Hearing disorder, 1951, 16:53-55.

5.          刘盈,石文惠,丁宝坤等.口吃患者MMPI与SAS,SDS的相关分析. 中国临床心理学杂志,2001,9(2):133-134.

6.          Perkins WH. Techniques for establishing fluency. In: Perkings WH,ed. Current therapy of communication disorder:stuttering disorders .New York, Thieme-Stratton Inc,1884:174-178.

7.        Rami, M.K., Kalinowski, J., Stuart, A. & Rastatter, M.P. (in press). Self-perceptions of speech language pathologists-in-training before and after pseudostutteing experiences on the telephone. Disability and Rehabilitation.

8.         Kalinowski, J. (2003) Self-reported efficacy of an all in-the-ear-canal prosthetic device to inhibit stuttering during one hundred hours of university teaching: an autobiographical clinical commentary, Disability and Rehabilitation, 25, 2, 107-111,

9.         Kalinowski, J. & Saltuklaroglu, T. (in press). Speaking with a mirror: Engagement of mirror neurons via choral speech and its derivatives induces stuttering inhibition. Medical Hypotheses.

10.     Kalinowski, J., & Saltuklaroglu, T. (in press). The inhibition of stuttering: A viable alternative to contemporary therapy. Family Medicine.

11.     Kalinowski, J. (2003). Self-reported efficacy of an all in-the-ear-canal prosthetic device to inhibit stuttering during one hundred hours of university teaching: a case study. Disability and Rehabilitation, 25, 107-111.

12.     Kalinowski, J., Dayalu, V. N., & Saltuklaroglu, T. (2002). Cautionary notes on interpreting the efficacy of treatment programs for children who stutter. International Journal of Language and Communication Disorders, 37, 359-61.

13.     Kalinowski, J., Armson, J., Roland-Mieszkowski, M., Stuart, A., & Gracco, V. (1993).  The effects of alterations in auditory feedback on stuttering frequency.  Language and Speech, 36, 1-16.  (Also appeared in Haskins Laboratories Status Reports on Speech Research, 1992, SR-111/11

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1.        泸州医学院附属医院耳鼻咽喉-头颈外科  四川 泸州 646000
2.  加拿大达尔豪斯大学研究生院



此文摘自《中国听力言语康复科学杂志》2006年第3期（总第16期）刊登在27、28页
【中图分类号】G764.5 【文献标识码】A  【文章编号】1672-4933(2006)-03-0027-02

顾客满意度调查

  2004年4月，Rainmaker & Sun Integrated Marketing公司受SpeechEasy口吃矫正器美国总代理商Janus Development 公司之托，对自2001年SpeechEasy开始销售以来的2548名使用者做了顾客满意度调查。

目的：本调查是为了收集关于SpeechEasy口吃矫正器使用效果的客观准确反馈信息。

调查结果：

2548名收到问卷的被调查者中，有489名（19%）做了回复，这已经是一个较大的、从统计角度讲相对恰当的样本大小。调查结果分为以下两个部分：

一、主要调查结论

1.       超过80%的思比易（SpeechEasy）用户对他们做出购买机器的决定感到满意。

2.       超过90%的人愿意向其它口吃者推荐思比易（SpeechEasy）作为一种选择。

3.       按1-10级分，10代表说话极流利，1代表说话极不流利，超过60%的人认为他们在使用思比易（SpeechEasy）之前的说话流利度只有5级或更低，使用后，75%的人认为自己的说话流利度达到7级或更高。

4.       三分之二的人认为他们配戴机器后说话流利度在持续改善。

5.       三分之二的人认为机器的效果达到或超过了他们的期望。

6.       大约80%的人回答，如果再做一次选择，他们还是会购买思比易（SpeechEasy）。

7.       超过80%的人回答，使用思比易（SpeechEasy）后比起使用前，对言语治疗效果感到更满意。

8.       超过85%的使用者反映自信心、自由度和自尊心得以增强，同时社会和职业关系得以改善。

9.       四分之三的人反映思比易（SpeechEasy）给他们的生活带来积极或非常积极的影响。

10.   三分之二的人认为说话流利程度有了好的或显著的改善。

11.   不管说话流利度的改善是一般还是很大，在以下几个方面都有体现：

1)             日常对话   
2)             商务会谈   
3)             朗读   
4)             电话   
5)             公众演讲

12.   约70%的人每周佩戴机器的时间为5-7天。

13.   超过70%的人每天佩戴机器的时间至少为4小时，约45%的人每天会戴7小时或更长的时间。

二、原始数据统计：

1.你购买思比易®（SpeechEasy®）机器多长时间？

1 - 3 个月  11.08% (51 / 460)
4 - 6 个月  20.00% (92 / 460)
7 – 12 个月 50.22% (231 / 460)
13 – 18 个月 10.65 %  (49 / 460)
19 - 24 个月  6.08 %  (28 / 460)
25 个月以上 1.96 %   (9 / 460)
平均时间:   0.807 years

2.你的年龄？

平均年龄:   34.301 years

3.你的性别？

男性:   78.5 % (377 / 480)
女性:   21.5% (103 / 480)

4.平均每周你有多少天佩戴思比易®（SpeechEasy®）机器？

1 天:   7.8 % (38/ 433)
2 天:   5.1 % (22 / 433)
3 天:   8.566 % (41 / 433)
4 天:   8.566 % (40 / 433)
5 天:   19.124 % (96 / 433)
6 天:   9.960 % (50 / 433)
7 天:   30.080 % (146 / 433)

5.平均每天你总共有多长时间在佩戴思比易®（SpeechEasy®）机器？

不到1小时:   10.4% (47 /454)
1-3 小时:   18.7 % (85 / 454)
4-6小时:   24.303 % (120 / 454)
7-9小时:   20.916 % (102 / 454)
10-12小时:   11.155 % (56 / 454)
超过12小时:   9.163 % (46 /454)

6.如果按1-10级分类，你认为你在使用思比易®（SpeechEasy®）机器前说话的流利程度为几级？假设1级为极不流利，10级为极流利。

1:   3.4 % (16 / 471)
2:   7.2 % (34 / 471)
3:   14.9% (70 / 471)
4:   18.9% (89/ 471)
5:   22.5% (106 / 471)
6:   15.7% (74 / 471)
7:   10.4 % (49 / 471)
8:   5.1 % (24 /471)
9:   1.3 % (6 / 471)
10:   0.6% (3 / 471)

7. 按同样的1-10级分类法，你认为佩戴了思比易®（SpeechEasy®）机器后，你目前说话的流利程度为几级？假设1级为极不流利，10级为极流利。

1:   0.6 % (3 / 464)
2:   1.1 % (5 / 464)
3:   3.4 % (16 / 464)
4:   5.8 % (27 / 464)
5:   8.5 % (39 / 464)
6:   5.8 % (27 / 464)
7:   16.6 % (77 / 464)
8:   30 % (139 / 464)
9:   24.1 % (112 / 464)
10:   4.1 % (19 / 464)

8.总的来说，你是否对做出购买思比易®（SpeechEasy®）机器的决定感到满意？

是:   80.6 % (371 / 460)
否:  19.4 % (89 / 460)

9.请告诉我们思比易®（SpeechEasy®）在哪些方面改善了你语言流利程度？（请仔细阅读所有供选择项）

商务会议:   30.266 % (148 / 489)
电话交流:   59.918 % (293 / 489)
私人谈话:   63.395 % (310 / 489)
外出就餐:   30.266 % (148 / 489)
运动:       6.135 % (30 / 489)
公众演讲:   40.491 % (198 / 489)
其它:       19.427 % (95 / 489)
以上选项均不是:   6.375 % (32 / 489)

10.你佩戴了思比易®（SpeechEasy®）机器后，是否有以下感受？（请仔细阅读所有供选择项）

工作进步:   21.677 % (106 / 489)
获得更好的职位:   4.703 % (23 / 489)
人际关系的压力减小:   33.742 % (165 / 489)
商务关系的压力减小:   29.243 % (143 / 489)
增强自尊心:   51.738 % (253 / 489)
改善生活质量  30.879 % (151 / 489)
改善社会关系:   37.014 % (181 / 489)
增强自信心:   60.941 % (298 / 489)
其它:   7.975 % (39 / 489)
以上选项均不是:   15.542 % (76 / 489)

11.以下哪一种描述最能反映你的意见？

极为积极的效果:   18.6 % (87 / 464)
积极的效果:   57.1 % (265 / 464)
无效果   21.1 % (98 / 464)
负面效果:   3.0 % (14 / 464)

12a.以下哪一项描述反映了你在佩戴机器头两个月时的感受？

无改善:   5.8 % (27 / 467)
改善程度很小:   29.3 % (137 / 467)
改善程度优良:   43.0 % (201 / 467)
极大改善:   21.8 % (102 / 467)

12b.与刚佩戴机器相比，以下哪一项描述反映了你现在使用思比易®（SpeechEasy®）的感受？

感觉一样:   34.2 % (156 / 456)
改善:   49.6 % (226 / 456)
更槽:   16.2 % (74 / 456)

13.在你选择思比易®（SpeechEasy®）机器之前，你接受过言语病理学家的治疗吗？

是:   79.9% (377 / 472)
否:   20.1% (95 / 472)

如果答案是肯定的，请选择你对治疗后说话流利度改善的满意程度。按1-10级分，1表示极不满意，10表示极满意。

1:   9.1 % (34 / 373)
2:   15.0 % (56 / 373)
3:   15.8 % (59 / 373)
4:   10.7 % (40 / 373)
5:   18.2 % (68 / 373)
6:   8.0 % (30 / 373)
7:   8.6 % (32 / 373)
8:   9.4 % (35 / 373)
9:   2.1 % (8 / 373)
10:   2.9 % (11 / 373)

14.自从购买了思比易®（SpeechEasy®）机器后，你还接受过与之相结合的其它治疗吗？

是:   22.0 % (103 / 467)
否:   78.0 % (364 / 467)

如果答案是肯定的, 请描述你对说话流利度改善的满意程度。按1-10级分，1表示极不满意，10表示极满意。

1:   5.5 % (6 / 110)
2:   4.5 % (5 / 110)
3:   3.6 % (4 / 110)
4:   7.3 % (8 / 110)
5:   11.8 % (13 / 110)
6:   10.0 % (11 / 110)
7:   19.1 % (21 / 110)
8:   21.8 % (24 / 110)
9:   10.0 % (11 / 110)
10:   6.4 % (7 / 110)

15.以下哪种描述确切地反映了你对思比易®（SpeechEasy®）机器的感受？

达到期望值:   46.4 % (215 / 463)
超出期望值:   17.3 % (80 / 463)
达不到期望值:   36.3 % (168 / 463)

16.如果需要你再做一次决定，你是否还会购买思比易®（SpeechEasy®）机器？

是:   78.9 % (361 / 457)
否:   21.1 % (96 / 457)

17.如果其它口吃者询问你他们是否需要考虑选择思比易®（SpeechEasy®）来改善说话流利度，你会说：

值得考虑:   90.6 % (423 / 467)
不值得考虑:   9.4 % (44 / 467)

我为思比易的问题辩护了几年, [令人可笑的是,   辩论的内容 (侮辱注册商标, 价位高,  广告内容) 与思比易的使用效果没有什么相关 ]今天是第一次看到这样翔实的资料.   过去没有刻意去了解, 也因为看不懂英文资料.   我感到这些资料很有说服力.

我想提一个问题:  中国人的使用效果与外国人的使用效果有什么区别吗?    按思比易矫正原理来说应当没有什么区别.    但是, 思比易对不同语言的口吃会有相同的效果吗?     如果有可能的话,  我建议在条件成熟时,  微迪公司在中国地区也作一个相同的调查,   对比一下调查结果,   我想这还是很有意义的.

愚公，您好！仅就您上面所提到的问题谈一下我个人的看法，可商榷。

1）、我个人认为，对于思比易国人的使用效果与外国人的使用效果没有本质区别。

2）、就统计数据看，国外关于使用效果的统计数据要略高于国内（见第5楼、7楼、8楼的文章，同时结合国内的数百份顾客回访记录），但总体有效率在75%-90%之间。

3）、这里面有一个看似矛盾的问题，从语言的发音习惯，拉丁语系的音节是发音的基本单位，汉字是汉语的基本发音单位，一个汉字/词对应的英文单词可能由多个音节构成。汉字如果一个字一个字的蹦，只要聆听者有耐心，还是基本能听懂，但对英文说，一个音节一个音节的蹦，将有很大可能把语意完全打乱，让聆听者不知所云。从这个意义上讲，矫正英文口吃者应该会比矫正中文困难些，使用效果也应该会比国内低一些。但为什么会出现相反的结果呢？我个人认为有以下主要因素：
a）、销售服务人员的素质和技巧差异。国内我们称为验配师，国外叫SLP（言语语言病理学家），国外的SLP有比较严格的政府资格认证，掌握了大量关于口吃的基础知识，包括各种传统疗法，对各种口吃症状的理解非常深入。而在国内，必须依靠我们自己去培养，这不光需要基础的培训，还需要大量的实践，我们曾经有过比较，不同的验配师（熟手和生手）去验配同样数量的口吃者，由于水平、技巧和对器械参数调整技巧的差异，其有效率的结果会大相径庭。
b）、口吃者工作、生活环境的差异，以及基础研究和舆论导向。在这些因素的综合作用下，我认为国外口吃者自身口吃症状的理解和对各种矫正方法的了解（如期望值等）无疑会更加客观和实事求是，这一点对口吃者的最终矫正效果是非常有好处的，千万不要说我崇洋媚外，我说的是事实。

4）、我想强调一句题外话，今年3月—4月我在美国见到的关于口吃矫正的基本现实是：基础研究领域百花争鸣，各种口吃矫正疗法并存并容。我买了几本口吃矫正的专著，由于太贵，都在50美圆以上，因此我不会象愚公您一样送给大家，但我会尽量抽出时间翻译一些摘要供大家分享。

另外，我不想在这个主题帖中进行辩论，请各位吃友理解！谢谢！

[SIZE="2"][/SIZE]

五、在欧盟委员会备案的思比易功效研究报告（中文摘要翻译件附后）

标题：
[B]A Summary Report of The Efficacy Studies of SpeechEasy: Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter[/B]

作者：
Dr. Tao Jiang
（注：作者系加拿大达尔豪斯大学大众传播与沟通失调系教授，美国听力学会高级会员，1997年获得加拿大国家言语疾病及听力学学会颁发的“大众传播杰出奖”）


Introduction

Based on the Evaluation Of Clinical Data : A Guide For Manufacturers And Notified Bodies, this report intends to summarize a number of efficacy studies on the Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter. After reviewing all the clinical data and published literature, we have selected those that meet the requirements by 90/385/EEC (AIMD) [1] and 93/42/EEC (MDD) [2] for the purpose of this report. Importantly, we are confident that the studies indicate SpeechEasy is in conformity with the intended purpose in relation to the safety and performance. The studies cited here are all peer reviewed and published in recognized academic journals, such as the International Journal of Language & Communication Disorders and American Annals of Biomedical Engineering. The devices used in those studies are exactly the same as those that Micro-DSP Technology Co., Ltd. manufactures and is presently applying for CE marking.

The reviewer of the article holds a post secondary degree in communication disorders and is presently an associate professor at School of Human Communication Disorders of Dalhousie University, Halifax, Canada. With all credentials, Dr. Jiang is capable of writing this report on SpeechEasy.

Background

The fact that stuttering is reduced when individuals who stutter speak under conditions of altered auditory feedback (AAF) has been evident for more than 45 years. Conditions of AAF known to reduce stuttering relative to non-AAF (NAF) include delayed auditory feedback (DAF) (Naylor 1953, Chase et al. 1961, Kalinowski et al. 1993, 1996, 1999, MacLeod et al. 1995), frequency-altered feedback (FAF) (Howell et al. 1987, Kalinowski, et al. 1993, Hargrave et al. 1994, MacLeod, et al. 1995, Stuart et al. 1996, 1997a, Armson and Stuart 1998), masked auditory feedback (MAF) (Shane 1955, Maraist and Hutton 1957, Kalinowski et al. 1993), and reverberation (Adamczyk et al. 1975, 1979, Smolka and Adamczyk 1992). MAF has been shown to be less efficient in reducing stuttering than DAF and FAF (Howell et al. 1987, Kalinowski et al. 1993). Kalinowski et al. (1993) and MacLeod et al. (1995) reported DAF and FAF to be equally effective in reducing stuttering, while Howell et al. (1987) in a seminal paper reported FAF to be more effective than DAF. Traditionally, forms of AAF have been generated by electronic signal processing devices, however, passive mechanical devices may produce AAF effects as well (Stuart et al. 1997b). The method in which AAF reduces stuttering remains undetermined. It was originally speculated that those who stutter had an abnormal speech–auditory feedback loop. It was thought that this abnormality was corrected or bypassed while speaking under DAF. Numerous models were proposed to describe the
nature of the potential cause/effect relationship (Cherry and Sayers 1956, Mysak 1966, Webster and Lubker 1968). Following the initial excitement, the importance of audition in stuttering, however, was diminished. The auditory system was discounted as an etiologic factor in stuttering based, in part, on the argument that it was too slow for on-line correction of speech (Borden 1979). This notion has since been challenged, as well (Stuart et al. 2002). Imaging studies have implicated the role of the auditory system on a central level and on a time scale compatible with Andrew Stuart et al. 2 LCD(gamma) LCD30727.3d 10/10/03 16:19:43 Rev 7.51n/W (Jan 20 2003) the behavioural effects of DAF on the overt manifestations of the disorder. It was also argued that the fluency enhancing properties of DAF and MAF were most likely due to an ‘altered’ manner of speaking (i.e. an emphasis on phonation achieved via slowing down through extended syllable duration; Wingate 1976, Perkins 1979). Similarly others have espoused the notion that ‘the functional variable in regard to the reduction of stuttering is not DAF, but prolonged speech, and the latter can be produced without reliance on a DAF machine’ (Costello- Ingham 1993: 30). In fact, almost all behavioural stuttering therapies from the
1800s to the present day have used slow speech rate in some form as a therapeutic
strategy (Van Riper 1973). Kalinowski and colleagues have since refuted the notion that a slow rate of speech is a necessary antecedent for stuttering reduction while one who stutters speaks under AAF. In a series of papers, they demonstrated that stuttering is
reduced under conditions of AAF while speaking at a fast intelligible rate of speech
(Kalinowski et al. 1993, 1996, Hargrave et al. 1994, MacLeod et al. 1995). Their results demonstrated reductions in stuttering rate between 70 and 90% regardless of speaking rate. This discovery contradicted the notion of the importance of slowed speech to fluency induced by AAF. That is, when syllable prolongation is eliminated, such as when speaking at a fast rate, the fluency enhancing properties of AAF are just as robust (i.e. a slowed speech rate is not a necessary antecedent for fluency improvement). It is reasonable, therefore, to speculate that the relevant variable(s) for fluency enhancement under conditions of AAF are related to auditory function. This shift necessitated a re-examination of the role of AAF in the reduction stuttering (Stuart and Kalinowski 1996).
At the same time, the stout findings of stuttering reduction with AAF were coupled with frustrating clinical observations. That is, those who stutter that were trained to reduce speech rate via specific articulatory/vocal targets did not always meet with clinical success. While speech may be more fluent following this traditional stuttering ‘motoric’ therapy approach, it was typically unnatural sounding (Runyan and Adams 1979, Martin et al. 1984, Metz et al. 1990, Runyan et al. 1990, Franken et al. 1992, Kalinowski et al. 1994) and not likely to be generalized from the therapy room to situations of daily living (e.g. Boberg 1981, Craig et al. 1996, Onslow et al. 1996). Put simply, relapse was frequent. The application of wearable prosthetic devices using AAF as an adjunct or alternative to current stuttering therapy became apparent and was voiced repeatedly (Armson et al. 1995, Kalinowski et al. 1995, 1995, 1996, Hargrave et al. 1994, MacLeod et al. 1995, Stuart et al. 1996, 1997a, Armson and Stuart 1998). The impetus behind the application of AAF in a prosthetic device for stuttering reduction was fivefold (Stuart et al. 2003): First, the reduction of stuttering under AAF is achieved virtually spontaneously with no conscious effort similar to that observed with choral or shadowed speech (Andrews et al. 1983, Armson et al. 1995). Second, AAF reduces stuttering in individuals with mild and severe stuttering without a sacrifice in perceived speech naturalness (White et al. 1995, Stuart et al. 2003). Third, stuttering reduction occurs during both the production of conversational speech and oral reading (Armson and Stuart 1998). Fourth, a significant reduction in stuttering rate can be achieved with monaural feedback
regardless of ear relative to NAF (Stuart et al. 1997a). Finally, the robust effects of
AAF occur outside the laboratory environment such as public speaking in front
of various audience sizes (Armson et al. 1997) and speaking on the telephone to
Altered auditory feedback in-the-ear devices 3 LCD(gamma) LCD30727.3d 10/10/03 16:19:43 Rev 7.51n/W (Jan 20 2003) strangers (Zimmerman et al. 1997). It has also been recently reported that repeated exposure after 3 months’ exposure to DAF outside the clinical environment with minimal clinical guidance produces a carry-over effect and significant reductions in stuttering are observed in the absence of AAF (Van Borsel et al. 2003). Prosthetic devices incorporating AAF have been available as a therapy alternative
in the past. Unfortunately, however, devices have not been cosmetically appealing (i.e. inconspicuous self-contained at the ear-level). That is, technology has been limited to conspicuous devices that are body worn incorporating additional head worn pieces for signal delivery (Donovan 1971, Gruber 1971, Grant 1973, Pollock et al. 1976, Low and Lindsay 1979). Only recently was a self-contained earlevel device for application with those who stutter achieved (Stuart et al. 2003). The recently developed device incorporates a microdigital signal processor core that reproduces the high fidelity of unaided listening and auditory self-monitoring while at the same time delivering AAF. DAF and FAF signals in combination or isolation can be generated to the user in a cosmetically appealing custom in-the-canal (ITC) and completely in-the-canal (CIC) design. Programming of the device was achieved through a personal computer, interface and fitting software.

In the past, there were many reports of success of using DAF and FAF to treat people with stuttering disorders with bulky devices in labs; however, recently, there have been some reports investigating the efficacy of SpeechEasy since 2000. I have selected some of research literature and present here for review.

Efficacy Studies

Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter have only been recently developed. A series of studies were carried out by researchers in USA, Canada and other parts of the world. However, a bulk of literature comes from Department of Communication Sciences and Disorders, East Carolina University, Greenville, NC, USA. This group consists of Andrew Stuart, Joseph Kalinowski, Michael P. Rastatter, Tim Saltuklaroglu and Vikram Dayalu, Tao Jiang, Peter Xia, John Jiang, et al. They have produced more than 50 papers on this topic. For the simplicity of this summary, I have selected two most recent efficacy studies since SpeechEasy was first developed in 2000.

The first one was conducted in 2001 after one year of its use. The title of this study was Four Months Efficacy Study of SpeechEasy and the results were presented in a poster session in the annual conference of American Speech and Hearing Association. In this study, 4 adults (ages 21-54) and 4 children (ages 9 – 16) with moderate to severe stuttering participated in this study. No participant had been diagnosed with any other speech, language, or hearing disorders. The primary selection criteria for participating in this study were a moderate to severe stuttering severity and a residing in the vicinity of Greenville, NC. Each of the participants was provided with a custom fit SpeechEasy device. The children were provided with ITC (in-the-canal) models of the SpeechEasy. The adults were provided with CIC (completely-in-the-canal) models of the SpeechEasy. Baseline measures of stuttering were recorded while reading and during conversation before implementing the SpeechEasy Protocol. Upon inserting the SpeechEasy in the ear, each participant underwent approximately 30 minutes of training in order to obtain maximum fluency enhancement from the SpeechEasy. This training included: sensory training to facilitate listening to the altered signal, and motor training - only when necessary to obtain higher fluency levels. These consisted of making small intermittent changes in speech production in order to ‘highlight’ the altered speech signal without compromising speech naturalness.

All participants returned once in the next 4 months for minor adjustments to the parameters of their SpeechEasy device. After approximately 4 months of continual use of the SpeechEasy (participants reported using the SpeechEasy device at least 7 hours per day), stuttering frequencies were again obtained for all participants. Frequency counts of stuttering were again conducted during reading and conversation, while using the SpeechEasy and without using the SpeechEasy. For all frequency counts of stuttering, approximately 300 syllables of speech were collected. Stuttering was defined as part-word repetitions, tension-filled prolongations and postural fixations. Statistical significance between frequency counts were computed by means of a series of paired sample T-tests (alpha = 0.05).

The results of the study indicate that the immediate fluency enhancement provided by implementing the SpeechEasy protocol appears to be stable after 4 months of continued use. No significant increases in stuttering frequencies were found in reading or conversation over time when the SpeechEasy was used. The SpeechEasy provides efficient and effective symptom management of stuttering. It does not appear to be a curative agent.

The second study was conducted at the same lab by the title of Investigations of the impact of altered auditory feedback in-the-ear devices on the speech of people who stutter: initial fitting and 4-month follow-up. It was published in International Journal of Language & Communication Disorders (2003, VOL. 38, NO. 00, 1–21). Aims of the studies examine the first therapeutic application of self-contained ear-level devices in three experiments. The effect of the device on the proportion of stuttered syllables and speech naturalness was investigated following initial fitting and at 4 months post-fitting. Methods & Procedures: Three experiments were undertaken: In Experiment 1, the effect of a self-contained in-the-ear device delivering AAF was investigated with those who stutter during reading and monologue. Two adolescents and five adults who stuttered read and produced monologue with and without a device fit monaurally. The device provided a frequency shift of z500 Hz in combination with a delayed auditory feedback of 60 ms. Custom-made ITC and CIC devices were fabricated for four adults and four youths in Experiment 2. The effect of group (i.e. youth versus adult), time (i.e. initial fitting versus 4-month follow-up), speech task (i.e. reading versus monologue), and device (i.e. present versus absent) on stuttering rate was examined. In Experiment 3, 15 naive listeners rated the speech naturalness of speech produced by the participants in Experiment 2. Speech samples from six conditions were rated: reading and monologue without the device at the initial visit, reading and monologue with the device at the initial visit, and reading and monologue with the device at 4 months.

Experiment 1

Two adolescent males, four adult males, and one adult female who stutter (M~21.9 years, SD~7.3), participated in Experiment 1. A self-contained in-the-ear prosthetic fluency device was used. The device components were manufactured by Micro-DSP (Chengdu, People’s Republic of China). Monaural device fittings were employed with all participants as no significant differences in stuttering rate for right versus left monaural conditions has been demonstrated (Stuart et al. 1997a). The test ear was randomly selected. The device settings were the same for all participants: FAF was set at 500 Hz up and combined with a DAF setting of 60 ms. Each participant in Experiment 1 read different 300-syllable passages extracted from junior high texts in social studies and science. Passages had similar theme and syntactic complexity. Participants produced 300 syllables of monologue speech. Both speech tasks were produced with and without a device. For all conditions, participants were instructed not to use any previously used or taught therapeutic strategies or techniques to control or reduce stuttering. A trained research assistant analyzed the speech samples from the video recordings. The first 300 syllables produced by the participants were analyzed for each condition. Means and standard errors for proportion of stuttered syllables per 300 syllables (i.e. number of stuttered syllables/300 syllables) as a function of device (i.e. present versus absent) and speech task (i.e. reading versus monologue) are analyzed. A two-factor analysis of variance with repeated measures was performed to investigate the effect of speech task and device on the proportion of stuttered syllables. the proportion of stuttered syllables was significantly reduced with the device in place regardless of reading or monologue. Stuttering events were significantly reduced with persons who stutter while experiencing AAF via an in-the-ear device. The proportion of stuttered syllables was reduced by approximately 90% during reading and 67% during monologue.

Experiment 2

In Experiment 2, Eight individuals with developmental stuttering participated in Experiment 2. Four participants were adults (M~38.0 years, SD~15.9) and four were youth (i.e. one child and three adolescents; M~12.5 years, SD~2.6). None of those enrolled in Experiment 1 described above participated in Experiment 2. The apparatus employed in Experiment 2 were the same as that in Experiment 1 with one exception: personal ear-level devices were constructed in either ITC or CIC custom-made shell designs. Monaural device fittings were employed with all participants. The same testing with instruction as described in Experiment 1 followed fitting and orientation: participants read 300 syllable passages and produced 300 syllables of monologue speech with and without a device. The device settings were the same for all participants: FAF was set at 500 Hz up and combined with a DAF setting of 60 ms. At 4 months post-fitting (¡1 week), participants returned to the clinic for follow-up testing. Participants again read different 300 syllable passages and produced 300 syllables of monologue speech with and without a device. In all, each participant produced eight samples of speech (i.e. four from the initial assessment and four from the assessment at 4 months). A count of stuttered syllables was determined from the video recordings for all participants for each condition. The first 300 syllables produced by the participants were analyzed for each condition. The research assistant and a second research assistant recalculated the number of stuttered syllables for 50% of the speech samples chosen at random. Means and standard errors for proportion of stuttered syllables per 300 syllables (i.e. number of stuttered syllables/300 syllables) as a function of group (i.e. youth versus adult), time (i.e. initial versus 4 months), speech task (i.e. reading versus monologue), and device (i.e. present versus absent) are analyzed. A four-factor mixed analysis of variance was performed to investigate differences in mean proportions of stuttering events as a function of group, time, speech task, and device. These findings indicate the proportion of stuttering events was significantly reduced with the device in place regardless of speech task or group and remained so after 4 months of time.

Experiment 3

Fifteen naive young adult undergraduate students attending East Carolina University, Greenville, NC, participated in Experiment 3 (M~23.1 years, SD~4.0; 4 males and 11 females). Twelve speech samples were extracted from the video recordings of each participant in Experiment 2. Two separate 15-s audio segments of uninterrupted speech were randomly selected from each participant’s speech production under the following six conditions in Experiment 2: reading and monologue without the device at initial visit, reading and monologue with the device at initial visit, and reading and monologue with the device at 4 months. Speech naturalness ratings took place in a classroom setting. Participants were asked to rate each speech sample without being provided an operational definition of speech naturalness. The listeners rated each track for naturalness in which ‘1’ was ‘highly natural’ and ‘9’ was ‘highly unnatural’. Verbal instructions were identical to that used by Martin et al. A 5-min rest was provided at the end of 48 tracks. In all four sets of contrasts, it was found that mean naturalness ratings of speech samples generated with the device were judged more natural sounding than those without the device. Naive listeners rated the speech samples produced by those who stutter while wearing the device significantly more natural sounding than those produced without Altered auditory feedback in-the-ear devices. This was true for both adult and youth, reading and monologue, and during initial fitting and at post-fitting follow-up. Put simply, the perceived naturalness of speech samples from people who stutter was significantly improved.

The findings of these experiments are threefold. First, it was demonstrated in Experiment 1 that an in-the-ear device electronically delivering AAF effectively reduced stuttering. Second, this is the first report of a reduction in the proportion of stuttered syllables evidenced with the device in place during reading and monologue for adults and youth at fitting and 4 months post-follow-up. Finally, naive listeners rated the speech produced by those who stutter while wearing the device significantly more natural sounding than without the device. Again, this was constant for adults and youth while reading and with monologue. This finding is consistent with previous reports of speech produced under FAF: White et al. (1995) reported clinicians evaluated speech produced by those who stutter under FAF as significantly more natural-sounding than their speech under NAF.

The third study was a technical investigation of SpeechEasy published in 2003 by the American Annals of Biomedical Engineering by Andrew Stuart1, Shixiong Xia2, Yining Jiang2, Tao Jiang2,3, Joseph Kalinowski1, & Michael P. Rastatter. The study was entitled as The First Self-Contained In-The-Ear Device To Deliver Altered Auditory Feedback: Applications For Stuttering. The purpose of the study was to describe and analyze the design and operating characteristics of the first self-contained in-the-ear device to deliver altered auditory feedback is described for applications with those who stutter. The ear-level device to inhibit stuttering was constructed in both an in-the-canal (ITC) and completely-in-the canal (CIC) hearing aid shell design. The shells were generated from an ear impression and fabricated by a standard light-curable acrylic shell mold material (Audalite™). In addition to the DSP core described above, both models incorporate an electret condenser microphone (Knowles TM4546 Self-Contained In-The-Ear Device To Deliver AAF 6 and Knowles EM4346 for the CIC and ITC model, respectively) and a Class D amplified magnetic receiver (Knowles ES3207). Both models utilize multiple channels, automatic gain control–input, adaptive feedback suppression, dual time constants, microphone noise suppression, and a noise attenuation algorithm. First, on a practical level, these devices free researchers from the reliance on generating
altered auditory feedback via devices that are not in situ (e.g., racks of electronic signal
processing equipment). Second, on an empirical level, the robust effects of DAF and FAF observed in laboratory and controlled situations of daily living suggest that the device should have some therapeutic success.


The fourth report was entitled Auditory Sidetone and the Management of Stuttering:
From Wollensak to SpeechEasy by Richard M. Merson, Coordinator of Clinical Research and Special Clinical Projects in the Speech-Language Pathology Department of
William Beaumont Hospital in Royal Oak, Michigan. In his study, he compiled the data from his patients fitted with SpeechEasy. In his study, he describes the seventy three SE Users that chose to purchase the SE after an evaluation at the Beaumont Stuttering Center. Fifty-four were males between the ages of 14 years and 67 years ( mean of 29.1) and 19 were females between the ages of 11 years and 66 years of age ( mean of 36.8). The results  indicate that the average reduction in stuttering ( stuttering=% syllables stuttered) after wearing the SE for at least one hour (immediate effect) was 79% for the males and 82% for the females. The immediate fluency effect ( % stuttering reduced) was noted in  91 of the 176 (52%) PWS who were evaluated for the SE had a 75% to 100% immediate fluency effect (reduction in stuttering). 49 of the 73 (67%) PWS who decided to purchase the SE had a 75% to 100% immediate fluency effect.

In conclusion, from the above four studies, it is clear that SpeechEasy is an effective therapeutic device to treat people with stuttering problems. In addition to achieving the effectiveness as evidenced in labs, it has more advantages in real world situations where naturalness and relaxed communication is required. The technical data as well as clinical data point out that the device meets all safety requirements and is in compliance with the risk analysis report provided by the manufacturer.


[SIZE="3"]中文摘要翻译：

[B]思比易功效研究报告概要：
―项运用AAF（改变听觉反馈）技术治疗口吃问题的耳内式产品[/B]
蒋涛 博士


简介
基于一些口吃临床数据上的研究， 我们采用改变听觉反馈原理而研发出了置于人体耳内的口吃矫正器。这里特别选择出一些符合90/385/EEC (AIMD) [1]和93/42/EEC (MDD) [2]标准并在行业知名刊物上同期发表的一些文章， 例如语言&传播失调国际月刊以及美国生物医学工程年报等。 我们相信思比易在安全和性能的指标是可以达到大家预期要求的水准的。 全文中提及这项产品正是由四川微迪数字技术有限公司生产的且正在申请CE认证的思比易。

背景资料

传统运用AAF原理研究治疗口吃已有45年历史，但这种单一被动接收声音信号的机械产品本身会产生AAF效应， 而导致了低下的治疗效果， 因此，运用AAF技术抑制口吃的方法至今没有得到业内认可。 同时， 随着DAF和FAF的原理在治疗口吃方面的成功案例和研究报告逐渐增多， 它们的科学性也逐渐被关注和认可。 但因初期开发的相关产品都外型笨重，不易患者携带因此最终没有成功投放市场。 思比易却是一项带有这项技术，且外形轻巧，秘密置于人体耳内的口吃矫正产品。 自2000年起， 关于它功效的调查试验报告就陆续在相关刊物上发表， 证明了它在口吃治疗方面的强大功效。

功效研究
将AAF技术应用在口吃矫正器上的研究在近几年又有了新的发展。 一系列的相关研究实验不断的在美国、加拿大和世界其它国家开展。 但绝大多数有实质意义的实验报告都是出自位于美国东卡罗莱那州大学的传播失调系的一群致力于口吃科学研究的学者们之手。 关于这个课题， 他们发表的论文就达50余篇之多。 在这里， 我们摘取了自思比易产品诞生以来的一些报告供大家参考借鉴。

第一项实验是在思比易投入市场一年以后进行的。 研究报告的题目是《使用思比易四月后效果调查》，这篇报告最终也以专栏的形式刊登在美国听力学年会的刊物上。 这项实验的主要方法，是邀请8名带有中重度口吃障碍的患者（4名成人，4名儿童）通过一些方法测定出他们的口吃严重度。 然后根据每人不同的特点，为他们定做了不同的思比易。 （儿童佩戴耳道式，成人佩戴完全耳内式）。 在他们练习思比易治疗口吃方案以前，通过观察他们阅读和对话测出他们的各项口吃参数， 作为接下来实验结果的参照标准。 在这些参与者带上思比易后，我们还对他们就如何正确使用思比易和达到最佳言语流畅度的相关技巧进行了30分钟的教授培训。

在他们八人佩戴思比易四个月后，我们重新邀请他们重新参与思比易的功效实验。 通过同样的方式比较他们佩戴思比易前后的口吃严重度。 搜集了他们阅读或谈话中的300个音节，并且确定了口吃的定义是出现单词重复、说同一单词时间超长等的现象。

最后通过各项测试方法， 得出患者使用思比易四月后的效果与刚佩戴时完全一样！在使用思比易的过程中， 患者的口吃出现频率不会出现大的增长。 可以肯定思比易为广大口吃人群提供了快捷高效的解决办法。

第二项研究是通过三项不同的小实验来观察口吃患者在刚刚验配思比易时和佩戴四月后的效果调查。 结果显示思比易有三重作用： 第一， 可以证明AAF原理在思比易――置于耳内式口吃矫正器上的应用非常成功和有效。 第二， 通过观察患者在佩戴思比易前后谈话和自言自语时出现口吃的音节的比例，发现思比易对减少出现口吃的音节和改善言语自然度上有很大的帮助。 第三， 以上结论与前面通过FAF（频率改变反馈原理）测试的结果完全一致。 利用FAF治疗口吃的效果远远比NAF（未使用听觉反馈原理）更明显。

第三项研究是由Andrew Start, Shixiong Xia, Yining Jiang, Tao Jiang, Joseph Kalinowskil, Michael P. Rastatter 共同设计实施的。 研究报告题为《改变听觉反馈技术在世界首创耳内式口吃矫正器上的成功应用》。 这项研究的目的在于分析耳内式口吃矫正器在设计和开发上如何最大程度地利用改变听觉反馈技术来治疗口吃问题的。

第四项研究的报告题为《听力的障碍以及如何正确的管理口吃》， 报告中， 研究人――Richards M. Merson, 根据他治疗过的口吃患者带上思比易的情况， 得出了一整套科学分析数据。 并且在73名佩戴思比易的患者中进行调查， 证明患者在带上思比易一小时后能够起到缓解口吃的效果的，男性中占79％， 女性占82％， 言语流畅度得到立即改善的， 占总人数的75％。

综上所述， 通过以上四项研究， 可以表明思比易确是一项治疗口吃的有效手段。 除了在试验室进行的这些试验所起到的效果以外， 它也能提高和改善人们说话的流畅度和松弛度。相关临床试验数据也证明了这项产品是完全达到相关安全标准以及制造商的风险分析报告的要求。[/SIZE]

（待续）

2002年9月16日 《people》杂志(人物周刊)发明家栏目关于思比易的报道

[CENTER][IMG]http://pic.the9safe.com/tmp/10/338834_L10eDRleNiysKx203icn.jpg[/IMG][/CENTER]

[CENTER][IMG]http://pic.the9safe.com/tmp/10/655346_0VLo0VQYfddsGcIC6gGX.jpg[/IMG]

[SIZE="6"][B]轻松说话[/B][/SIZE]
[SIZE="5"]口吃障碍者Joseph Kalinowski与人合作发明了一种克服口吃的产品[/SIZE][/CENTER]

[SIZE="4"]Joseph Kalinowski 在马萨诸塞州梅纳德镇长大，这是一个临近波士顿的小城镇。四十三岁的他一直以来深受口吃的影响，他说：“我常常向上帝祈祷，为了赶走口吃，我宁愿他取走我的胳膊。”

美国现今有三百多万人饱受口吃之苦。作为位于北卡罗莱纳州格林威尔市东卡罗莱纳大学的一名言语病理学教授，Kalinowski的确为此做了很多的工作。一年前，他和同事Michael Rastatter及Andrew Stuart发明了SpeechEasy。这是一种外观近似助听器的产品，能让使用者几乎在说话的同时听到自已声音的另一种音调的回声。这种所谓的“合唱效应”— 就像Kalinowski小时侯和同学们一起朗读誓言一样，可以抑制口吃。虽然早在二十世纪六十年代就有了可以模拟这种效果的产品，Kalinowski的这项发明仍然是第一次让该种产品具有了如此的隐藏性和舒适性，可以为人们在日常生活中所用。然而，这则受口吃障碍者欢迎的消息受到传统治疗方式的抵触。通常的传统方式需要做大量的行为练习，而且并非总是管用。位于纽约的国家口吃中心的执行董事Martin F.Schwartz说：“这种产品应该进入每一个口吃治疗诊所，同其它的治疗方式放在一起供人们选择。”

Schwartz同时也指出，SpeechEasy的长期功效还没有得到证实。不过，Kalinowski自从拥有了这台价值四千美元，还不包括保险的口吃矫正器后，让他很乐观。他在1992年于康涅狄格大学获得言语病理学家的博士学位后，一直对自己的口吃很敏感，有时在餐厅里还让他的妻子,40岁的Barbara，同样是一位言语病理学家，或者是9岁的女儿Amy和11岁的女儿Alissa帮忙点餐。2001年4月，经过十年的研究工作，他成了第一位使用自己发明成果的人。他把这看成是对那个过去一直饱受口吃痛苦的小男孩的礼物。他说：“那个孩子至今仍然留在我的记忆里。看到人们使用这项产品真让我感到满足。它能带给人们帮助，同时具有深远的影响。”[/SIZE]

nce: 美国口吃协会对思比易的态度

--------------------------------------------------------------------------------
主题：美国口吃协会对思比易的态度

作者: nce
本帖转自社区争鸣论坛

下面转述美国口吃协会对思比易的看法，原文过长，恕不全文翻译。

中心意思是：思比易的效果因人而异，有些人很有效，有些人无效。况且，每个口吃者对于“成功”的定义不同，要确切统计有效率是一件困难的事。美国口吃协会不会公开支持任何一种单一的治疗方案。 并且对任何一种声称有效的方法持谨慎的态度，无论是传统疗法还是矫正仪器。（还有一句很重要的话：）要真正克服或有效的控制口吃，勤奋和努力是最主要的因素。

下面谈谈我个人的看法：我在去年曾试戴过一阵思比易，确实有一些帮助，但并未达到我满意的程度，所以没有买。在思比易的国际论坛上，用户的反应也是褒贬不一。所以家境好的朋友不妨尝试一下。也希望思比易厂家能适当延长试用期，让用户能更放心的购买，因为我也看到和听说过一些随着时间的推移思比易的效果下降变得无效的情况。

The National Stuttering Association's Position　on the Speech Easy and other assistive devices
Dear NSA?/H4>
"I recently heard about the SpeechEasy 'anti-stuttering' device. Should I buy one?"
The SpeechEasy device, available from Janus Development ([url]www.speecheasy.com)[/url], has received widespread publicity during the past few years. The NSA knows that many people who stutter and their family members have questions about the device, and we are eager to provide information about this device. A major of mission of the NSA is to help people find the treatment approach or solution that is right for them.

How assistive devices work
The SpeechEasy is, in essence, a digital hearing aid that provides Delayed Auditory Altered Feedback (DAF), as well as Frequency Altered Feedback (FAF). It has long been known that many, though not all, people who stutter experience increases in their speech fluency when speaking under DAF and FAF. The specific reason for this increased fluency is not at all clear. Still, numerous devices to help people speak more fluently have been developed over the past 50-60 years. These include the Edinburgh Masker, the Fluency Master, and others. The SpeechEasy builds upon prior efforts by offering DAF and FAF in a miniaturized package.

Experience to date
Researchers, clinicians, and members of the stuttering community appear to be divided regarding the use of the SpeechEasy. Some people are strong advocates of the device, while others are strong opponents. Unfortunately, at present, there are no published, independent studies that show what percentage of the population of people who stutter are likely to benefit from the SpeechEasy. To be sure, many people have received varying degrees of benefit from the device; however, it is impossible to say who will benefit and who will not. Here at the NSA, we have heard from many members who have tried the SpeechEasy. Like all things, though, there are some who have found success and some who have not. It is important to recognize that different people have different definitions of "success." For example, some individuals might experience considerably increased fluency in most speaking situations, while others may only use it in very specific contexts. Still others receive very little benefit from the device.

Indeed, in a recent survey of NSA members, 125 of 701 respondents reported using a feedback or speech pacer device such as DAF, masker, Fluency Master, Pacemaster, etc. Of those, 38% reported that their experience with the device was not at all successful; 44% said their experience was somewhat successful; and 18% reported their experience was very successful. Thus, different people have different experiences. It is important to note that this survey was conducted before use of the SpeechEasy was widespread, so these results do not relate directly to the SpeechEasy. One might guess that these findings could be similar to the experiences of individuals who use the Speech Easy device, though only further research will provide the information we need.

Long-term effects are unclear
One of the questions that has been raised about the SpeechEasy is how long the effects will last for those people who do experience improved fluency. Prior efforts to use DAF and FAF have resulted in only temporary gains-as people habituate to the device, the benefits in fluency tend to diminish over time. It is not clear, at this point, whether the SpeechEasy will also be affected by habituation, though research is currently underway to address this and other relevant questions. In all likelihood, some people will experience habituation and a loss of treatment effects over time, while others will find that their fluency gains that are more durable. It should be noted that these are the same sorts of issues and problems that have been identified with traditional approaches to stuttering treatment, so individuals should always be prepared to gather information and ask questions about outcomes, regardless of which approach they have selected.

Limitations of assistive devices
Fluency gains are only present with people are actually using the device. In this way, the SpeechEasy is like glasses卛t does not fix the underlying problem (stuttering or poor vision); it simply provides a way of compensating for that problem. Some of our members have found it difficult to use SpeechEasy meaningfully in some speaking situations. Because the device is only worn in one ear, the speaker hears competing signals - normal feedback in one ear and frequency-altered, delayed feedback in the other ear. Some NSA members have found this distracting, particularly in noisy environments or social settings. Thus, although some people have found that the device helps them speak more fluently, they have also found that it can be difficult to use at times. These limitations have prompted some of our members to use their devices only in certain situations, and some have stopped using them entirely.

Caution for parents
Finally, perhaps the most important question that has arisen is whether or not the SpeechEasy should be used with children. Although the SpeechEasy may prove to be a viable treatment alternative for some adults who stutter, many speech-language pathologists and people who stutter believe that we should be much more cautious about the use of such devices with children. At the NSA ,we feel that such caution is definitely warranted - we do need to be more careful about treatment provided to children who stutter. At present we simply do not have sufficient information to make an informed judgment. There are no published studies demonstrating the efficacy or safety of using the SpeechEasy with children. Therefore, the more cautious approach would be to wait to learn the results of ongoing research on the SpeechEasy before recommending its use with children.

Years of experience and research have shown that people who stutter are such a diverse population that no single remedy - be it a therapy program, an assistive device, or a medication - will work for everyone. Although we often hear of "new" treatments or miracle cures, to date, no single approach has proven to be effective for all people who stutter. Thus, the NSA fully supports research into effective treatments for stuttering. It is only through ongoing evaluation and research that people who stutter and therapists alike will be able to determine which treatment options are most viable.

Advice to consumers
At the NSA, we believe that all people who stutter should carefully consider the many treatment options that are available and make their own decisions about what is right for them. For some people, this may include devices such as the SpeechEasy; for others, it will not. One thing we do know, however, is that reducing the number of disruptions in a person's speech is only part of effective management of stuttering. Although many people who stutter can increase their fluency, through a variety of methods, many also benefit from assistance in dealing with the emotional consequences of a lifetime of stuttering. The professionals who are best qualified to help people who stutter deal with these negative consequences are speech-language pathologists, preferably board-recognized specialists in fluency disorders, working on conjunction with stuttering support groups such as the National Stuttering Association.

In should be emphasized that any approach to treatment-including speech therapy, use of an assistive device, or self-help-will have strengths and weaknesses. Individuals who stutter will always need to be motivated toward success and have confidence in the treatment process. The common denominator for all improvements in communication is that effort and hard work are needed to truly overcome and cope with stuttering.

Today, there is more help available for people who stutter than ever before, and the research currently in progress offers much hope for the future. People who stutter can benefit from educating themselves about stuttering and considering all available treatment options before making choices about what is best for their individual needs. For that reason, the NSA does not endorse any single approach to treating stuttering, and we tend to be very cautious about new claims of effective remedies, whether they be traditional speech therapy approaches, medications, or fluency enhancing devices.

We hope this information will be helpful to you, and we thank you for bringing your question to the National Stuttering Association. The NSA serves adults and children who stutter through education, advocacy, education, and support. The nonprofit organization, founded in 1977, has more than 80 local chapters nationwide. We sponsor workshops and youth programs around the country and publish a growing list of publications and booklets about stuttering for people who stutter, their families, and the clinicians who serve them.

If we can be of any further assistance, please don't hesitate to contact us at [email]info@WeStutter.org[/email]. You can also get information at our website, [url]www.WeStutter.org[/url] or by calling 1 (800) We Stutter (937-8888).

［此帖子已被 nce 在 2006-09-16 19:53:17 编辑过］

黄逸说: 口吃治疗仪在北美上市,得到学术界的一致认可

“HZZ-1型口吃治疗仪”是根据深度听觉延迟反馈理论（DAF）研制的新一代口吃矫正仪器(中文名称叫语通---愚公说明)，曾荣获国家发明专利（专利号ZL 92 1 14185.8），系模拟信号延迟方法用于口吃治疗的国内唯一专利，其技术含金量远远超过目前已有的口吃治疗仪器，

[B]与之相似的仪器(其中应当包括思比易---愚公说明)已经在美国、加拿大等国家上市，同样得到了学术界的一致认可。[/B]

自2000年以来，该仪器经过近百名口吃患者的试用，证明疗效确切，无任何副作用。

[摘自主题：[注意]复旦大学附属医院口吃治疗仪临床验证,欢迎协会会员参加]

[发表时间：2004-05-09 20:42:17　 摘自上海协会论坛]

哪位朋友能抽时间把第１３楼的英文帖子给翻译一下（主题：美国口吃协会对思比易的态度）

多谢了！

13楼的文章翻译

该文是在2005年2月16日由J. Scott Yaruss, Ph.D., CCC-SLP（言语病理学家）发表在NSA网站上的一片文章，试着翻译了一下，请专家多多指教。
原文网址：[url]http://www.nsastutter.org//search/dsp_results.php?tbl=material&mixid=328[/url]

译文如下：

“我最近听说口吃矫正器“思比易”，我可以买一个吗？“

在过去的几年里，美国Janus公司的思比易被广大社会认可。NSA了解许多口吃患者和家庭成员对此仪器仍然持有疑问，我们也非常积极努力地提供相关的产品信息供大家参考。NSA的主要使命就是帮助人们找到相关可行正确的治疗方法来治疗口吃。

该仪器的工作原理

“思比易”，本质上讲就是一种提供DAF的数字助听器，此声音延迟反馈（DAF）与频率转换反馈（FAF）工作原理是一样的。长期以来，大多数遭遇口吃困境的患者对于通过DAF和FAF工作原理来提高说话的速度都深有体会，而对于改善后的话语频率也并非相当清晰，对此原因，许多像爱丁堡掩蔽器、频率掩蔽器此类仪器都经历了50-60年的发展研究来帮助缓解口吃提高频率清晰度，而思比易则是建立在以最小的体积，以DAF和FAF原理效应达到优先效果。

目前的经验

对使用思比易看法，许多科研人员、临床专家和口吃协会的会员都各抒己见，一方是非常赞成，而另一方却是强烈反对。从目前状况来讲，一些自主研究者发现口吃患者通过思比易产生效果的比例数据却没有在社会上公示。但是非常肯定的是，的确有不少患者在使用思比易后都有不同程度的效果，但是，我们也不可能说谁的效果好谁又没有效果。在NSA中我们已经所闻到有试带过思比易的患者的反馈，有的非常成功疗效显著，而有的却没有任何效果。显然，不同的人对“成功，有疗效”的定义是不一样的，如在一部分人在详细的谈话中只使用此仪器的同时，一部分患者明显在语言环境中感受经历说话频率提高的快感，相反，也有部分患者没有得到效果。

实际上，在近期的NSA会员的调查中，701人当中就有125人在使用语言同步器或者声音反馈相关仪器，如：DAF、掩蔽器、频率掩蔽器、同步掩蔽器等等。当然，有38%的患者表示在使用仪器后没有任何效果；有44%的人感觉有些效果；18%人感觉效果非常好。由此说明，不同的人有不同的体验效果。但是需要注意的是这个数据是在广泛使用思比易.之前而调查的，因此这数据与思比易.毫无关系。虽然我们需要更深层次的研究信息，但是会有人猜想这些数据结果跟使用了思比易.效果相似。

关于思比易的其中一个问题就是其疗效对于那些已经提高了说话频率的患者来说能持续多久。以前患者依赖于仪器时，DAF和FAF会导致暂时性的增益，其频率疗效会不断减弱。虽然研究者还在不断探索其所涉及到的问题，并将其研究结果公布与众，但是对于思比易能否象其他仪器一样在习惯依赖思比易时被影响其疗效，这个问题还不是很明确。同样，当一部分人发现他们的频率增益具有持久性的同时，另外一部分人的疗效在不断减弱丧失和在不断依赖中。应该注意到的是，以其他传统治疗口吃的方法所产生的问题争议相比，这些问题争议都是相同的，因此应该不计治疗方法的收集相关的信息问题和其治疗结果。

使用该仪器会带给人们仅仅只是流畅的增益。以此方法，思比易就像一幅眼镜不可能解决根本性的问题（口吃或弱视力），只是简单的一种能提供弥补解决问题的途径。我们其中一些会员发现很难在一些语境中有意义的使用思比易，因为这个仪器只是佩戴在一只耳朵上，话者听两只耳朵产生不同信号-普通的声音反馈在一只耳朵里，而改变频率和延迟反馈却在另一只耳朵里。一部分NSA会员发现特别在喧闹的环境和社会场景里会分散注意力，因此，虽然一些人发现此仪器会帮助他们说话更加流畅，但是却很难不时地使用。这些局限性就表现在特定的环境中提醒及时地使用辅助工具，而有一部分人却已经完全停止使用。

最后，可能最重要的问题是孩子们是否应该使用思比易。虽然使用思比易被证明对成年口吃患者是一种可行的治疗方法，然而许多言语病理学家和口吃患者认为儿童使用如此的仪器应该更加的谨慎。对于NSA，我们认为这样的谨慎是应该被明确的提出--对于儿童口吃的治疗我们确实需要更加的谨慎。目前，我们还没有获得足够的信息以做出十分精准的判断，也没有公开地研究能证明儿童使用思比易的功效或者安全情况。因此，更加谨慎的方法是在等待获取正在进行的思比易研究结果后，然后推荐思比易给儿童使用。

多年的经验和研究显示口吃患者是一个多样人群，没有单一的治疗法适合所有患者，无论它是一种治疗方案，或者单一的治疗仪器，或者单独的药物治疗。虽然我们经常听到一些新的治疗方法或是奇迹般的疗效，但是到目前为止，没有任何单一的治疗方法被证明能够适合于所有口吃患者。因此，NSA完全支持任何能够有效治疗口吃的研究。也只有通过对口吃患者适时的研究和评估，诸如临床医学家才能够决定什么治疗方案对患者个体最为切实可行。

在NSA，我们认为所有的口吃患者都应该对众多可以采用的治疗方法进行仔细考虑，并决定哪种最为适合自己进行治疗。对于有些人，他们可能选择诸如思比易的治疗仪器予以治疗，而对其他人，他们则不会。有件事我们确实知道，不管用何种方法，减少言语中断仅仅是有效治疗口吃的一部分，虽然许多口吃患者通过不同的治疗方法能够增加言语流畅，许多患者也能够从情绪性口吃的治疗受益。最有资格帮助口吃患者治疗这些消极结果的是言语病理学家，广泛认可的言语流利失调治疗专家以及与他们联系的口吃支持团体诸如NSA。

应该强调任何可行的治疗包括言语治疗、使用辅助设备或者自我恢复都有强有弱。口吃患者需要保持成功的主动性并且在治疗过程中坚定信心。通常所有言语交流的改善都需要艰苦努力地应对并克服口吃。

今天，口吃患者比以往能够获得更多的帮助，并且当前研究所取得的进步将会使今后的治疗更具希望。口吃患者通过教育培训获得口吃以及治疗口吃的多种治疗方法，最终能够选择最适合自己的治疗。基于此，NSA不会赞同任何单一的方法去治疗口吃，并且我们往往对新的有效治疗法保持谨慎，无论他们是传统的言语治疗手段，药物治疗或者是增强言语流利性的仪器。

我们希望以上的信息对你有所帮助，同时我们也感谢你对NSA提出的问题。NSA通过教育、辩明、培训为广大成年及儿童口吃患者服务。作为非赢利组织，NSA自1977年建立以来，已在全国80多个地方发展了分支机构。我们在全国范围内赞助工厂及初期的项目，并且面向广大口吃患者及其家庭，以及为他们诊疗的临床医生出版关于口吃方面的出版物及宣传册。如果任何进一步的帮助我们能够提供的话，请联系我们：
邮箱：info@WeStutter.org.
网址：[url]www.WeStutter.org[/url]
电话：1 (800) We Stutter (937-8888)

此文章是由以下作者研究发表
J. Scott Yaruss, Ph.D., CCC-SLP 哲学博士J. Scott Yaruss
Board-Recognized Specialist and Mentor in Fluency Disorders, Associate Professor, University of Pittsburgh, Clinical Research Consultant, Children's Hospital of Pittsburgh, Co-Director, Stuttering Center of Western Pennsylvania, Professional Relations Chair, Board of Directors, National Stuttering Association, Steering Committee, ASHA Special Interest Division for Fluency DisordersAddress: 4033 Forbes Tower, Pittsburgh, PA 15260
著名美国匹兹堡大学副教授，临床研究顾问，言语障碍专家导师，美国匹兹堡儿童医院与美国宾夕法尼亚州西部口吃中心合作懂事，专业人际交流关系主席，美国社会卫生协会言语障碍特殊利益部
地址为：4033 Forbes Tower, Pittsburgh, PA 15260
Office: (412) 383-6538办公室
Lab: (412) 383-6574实验室
Fax: (412) 383-6791传真
Email: [email]jsyaruss@csd.pitt.edu[/email]电邮
Department URL: [url]http://www.shrs.pitt.edu/csd/about/faculty/yaruss.html部门网站[/url]
Stuttering Center: [url]http://www.stutteringcenter.org口吃中心网站[/url]
AND...
Rodney Gabel, Ph.D.
哲学博士Rodney Gabel
Assistant Professor 助理教授
Bowling Green State University美国鲍林格林国家大学
Department of Communication Disorders 语言交流障碍部
Bowling Green, Ohio 43403美国俄亥俄州鲍林格林 43403
Phone: 419-372-7168 电话
FAX: 419-372-8089 传真
email: [email]rgabel@bgnet.bgsu.edu[/email]
________________________________________
Other links relating to fluency enhancing devices:
有关提高说话频率仪器的其他连接方式
Electronic Devices and Stuttering Treatment on the Stuttering Home Page.  This page is especially useful as it contains additional links to many other commentaries on this topic.在口吃主页中的电子仪器和口吃治疗文章。这篇文章包含了有关此话题的许多其他注释连接，因此特别有用。
________________________________________
This paper was edited by Jim McClure, [email]jim@jamcclure.com[/email], and published by Russ Hicks, [email]russhicks@mail.com[/email], webmaster for the NSA, February 16, 2005
这篇文章是由Jim McClure编辑（jim@jamcclure.com），由Russ Hicks出版（russhicks@mail.com），NSA网站管理员，2005年2月16号

SpeechEasyTM（思比易TM）美国市场的最新反馈摘要
（2006年5 月）
1. 验配成功率仍然保持在80%；
2. 用户的最低年龄：4 岁；最高年龄：96 岁；
3. 用户的平均年龄：33 岁，大多数用户为18—40 岁的男性；
4. 在产品试戴期内放弃使用SpeechEasy 的用户比率为11%；而购买后放弃
使用的用户比率难以统计，理由是很少有言语语言病理学家（SLP）接到
用户在此方面的抱怨或投诉；
5. 低于16 岁的用户比率为5—10%，且有一定的增长趋势，原因是
SpeechEasy 在美国青少年人群中接受度的不断提高；
6. 男性和女性用户的比率约5:1；

思比易TM口吃矫正器长期临床试验：使用模式和满意度调查结果

思比易TM口吃矫正器长期临床试验：使用模式和满意度调查结果  
[url]www.chineseaudiology.com[/url] 市场聚焦  2007年3月2日

原文来自《中国听力学》网站
网址：[url]http://www.chineseaudiology.com/News/news_detail.asp?id=1428[/url]

研究背景

　　目前的数据只是受试者从最初参加到完成一年疗效研究的中间结果。数据反映了对思比易效果的初步评估，在所有临床数据收集完整后需要进行更多正式的随机评估分析。本研究通过对每个受试者在使用6月后进行的问卷调查，报道思比易的实际使用模式和满意度，

研究方案设计

 合适的样本量（35名思比易使用者，10名对照）
 真实反映目前思比易供应商的典型验配模式
 多个评估点（基线水平，使用设备后的1，3，6，12月）
 受试者不承担任何费用
 12个月的临床试验期间不能接受其它任何治疗
方法

受试者纳入标准
 病史证明患发展性口吃
 听力正常或接近正常
 表现出明显的口吃行为
 对思比易治疗为阳性反应（与基线水平相比口吃频率降低20％）
 对照组满足前三项标准

临床评测方法（在基线水平，使用设备后的1，3，6，12月进行）

言语测量
 口吃言语百分比，速率，言语正常率，口吃严重程度评估工具－3，门诊实际对话、段落朗读、电话交谈样本，诊所外与不熟悉对象的对话样本。

定性测量
 改良Erickson交流方式量表（s－24）;口吃感知问卷（PSI），说话者所经历口吃的全面评估（OASES）
受试者调查表
 使用模式（估计使用时间/天,不同情况使用模式）
 满意度测量（有效率/不同情况下，满意率/不同情况下，言语正常率的自我评定）

结 果

试验完成情况
 30名受试者纳入试验研究
 5名受试者（16.67%）退出试验，一般在1月或3月进行回访时。这与厂家（JDP）所报道的在60天之内有12％用户退回设备相吻合。
 20名受试者完成至少6个月的使用期，尽管其中有患者由于状态不稳定错过1次或几次评估。本文的数据只包括16名完成全部评估测量的受试者。
 8名受试者完成12个月的试验

退出研究的原因
 总体上满意设备，但是在高噪声的工作环境中使用困难（3月）
 满意设备，但是由于口吃症状轻，不用思比易说话也较正常，认为获益不大（3月）
 使用1月后评估：不流利的情况又接近基线水平，而且不喜欢为得到更流利说话状态的变更设置。（1月）
 满意设备，但是通常需要在高背景噪声的环境下使用，而这种环境下使用令人不适（3月）
 较满意设备，但不能完全达到患者的期望值（1月），应用了其它治疗方法。

使用模式
工作日
A：早上
 3(19%) 起床后就开始佩戴或在家时佩戴
 7(44%) 开始上班或上学时佩戴
 4(25%) 需要的时候佩戴（和别人交谈，打电话等）
 2(12%) 其它

B：工作、学校时间
 7(44%)整个工作、学习时间都佩戴思比易
 5(31%)只在需要的时候佩戴
 2(12%)只在特殊情况下取下思比易（如高噪声环境）
 1(6%) 通常在工作时间都不佩戴
 1 (6%) 其它
C．晚上、回家后
 10(62%) 一回家就取下设备
 2(12%) 回家后继续佩戴
 4(25%) 回家后需要的时候才佩戴（如：打电话，家里有客人等）
 0 其它
周末
 1 (6%) 周末全天佩戴
 12(75%)只在特别情况下佩戴（外出到公共场合、打电话）
 2(12%) 周末不佩戴
 1(6%) 其它

平均每天佩戴时间
工作日
0 不佩戴 4(25%)>2 小时 2(12%)2-4 小时 1(6%) 4-6 小时 3(19%) 6-8 小时
3(19%) 8-10 小时 2(12%) 10-12 小时 1(6%) >12 小时
周末
2 不佩戴 9(56%)> 2 小时 2(12%) 2-4小时　　1(6%) 4-6 小时 0 6-8 小时　　
1(6%) 8-10 小时　　 0 10-12 小时　　0>12 小时

满意度（6月评估）M＝均值，R＝分值范围

此时只获得初步的测量结果
1．使用积极的聆听技巧:
当你说话时，是否总是花费很大的努力来积极的聆听思比易发出的信号声（1＝从不，7＝一直）（M＝4.1,R=2-7)
2．使用积极的说话技巧：
当你佩戴思比易说话时，使用起始声（如：“啊 ”，“嗯”）的频率？（1＝从不，7＝一直）（M＝3.6,R=1-7)
3.使用思比易的容易程度
你会花费多大的努力使用思比易控制口吃？（1＝毫不费力，7＝相当费力）（M=1.4,R=1-3)
4．思比易治疗口吃的总体效果
总体讲，在你说话时思比易控制你口吃的效果如何？（1＝效果甚微，7＝非常流利）(M=5.7,R=4-7)
5．在最困难的说话情形下，思比易控制口吃的效果
在你说话最困难的情况下，思比易控制你口吃的效果如何？（1＝效果甚微，7＝非常流利）(M=4.4,R=3-7)
6．在最轻松的说话情形下，思比易控制口吃的效果
在你说话最轻松的情况下，思比易控制你口吃的效果如何？（1＝效果甚微，7＝非常流利）(M=5.9,R=5-7)
7．思比易对回避情况的改善
在使用思比易之前，你先前回避说话的情况有无改善？（1＝改善很小，7＝改善很大）(M=4.2,R=1-7)
8．思比易对词语回避的改善
由于使用了思比易，你是否愿意选择不回避去说出那些困难的词语？（1＝改善很小，7＝改善很大）(M=4.4,R=2-7)
9．对思比易的总体满意度：
你对思比易口吃矫正器的总体满意程度？（1＝不满意，7＝非常满意）(M=5.9,R=3-7)
10．对思比易的期望值
在思比易达到最初的期望效果方面，你最近（从上次回访开始）对思比易的感受如何？
（1＝未满足期望，7＝完全达到期望）(M=5.2,R=3-7)
11．使用思比易的容易性
在维护思比易，使之保持良好工作状态方面，你所做的努力如何（如：清洁、保持干燥、电池使用和更好）？（1＝毫不费力，7＝相当费力）(M=1.4,R=1-3)

结 论

受试者间使用模式的变化很大，少数人只在相当困难的说话情形下使用，这种情况在年轻受试者中特别明显。很少受试者在使用思比易后，感受到口吃行为完全消失，而个别受试者认为治疗效果逐渐下降。但总体讲，所有受试者都继续给出很高的满意度评价。

思比易TM口吃矫正器长期临床试验：态度/感知方面的测量

思比易TM口吃矫正器长期临床试验：态度/感知方面的测量  
[url]www.chineseaudiology.com[/url] 市场聚焦  2007年3月6日

原文来自《中国听力学》网站
网址：[url]http://www.chineseaudiology.com/News/news_detail.asp?id=1432[/url]

  研究背景目前的数据只是受试者从最初参加到完成一年疗效研究的中间结果。数据反映了对思比易效
果的初步评估，在所有临床数据收集完整后需要进行更多正式的随机评估分析。本研究反映了对初始参与
者的定性评估。

研究方案设计


合适的样本量
（35名思比易使用者，10名对照）


真实反映目前思比易供应商的典型验配模式


多个评估点（基线水平，使用设备后的1，3，6，12月）


多种测量评估手段（言语生成测量，生活态度/质量，使用模式，满意率）


受试者不承担任何费用


12个月的临床试验期间不能接受其它任何治疗



方法

受试者纳入标准


病史证明患发展性口吃


听力正常或接近正常


表现出明显的口吃行为


对思比易治疗为阳性反应（与基线水平相比口吃频率降低20％）


对照组满足前三项标准临床



评测方法（在基线水平，使用设备后的1，3，6，12月）
言语测量


口吃言语百分比，速率，言语正常率，口吃严重程度评估工具－3，门诊实际对话、段落朗读、电话交谈
样本，诊所外与不熟悉对象的对话样本。

定性测量


改良Erickson交流方式量表（s－24）;口吃感知问卷（PSI），说话者所经历口吃的全面评估（OASES）
受试者调查表


使用模式（估计使用时间/天,不同情况使用模式）


满意度测量（有效率/不同情况下，满意率/不同情况下，言语正常率的自我评定）

结 果

　　<口吃感知问卷（PSI）

表1（A）：口吃感知问卷总体得分。前4名完成最初一年临床试验受试者基线、1，3，6，12月评估数据


表1（B）：口吃感知问卷总体得分。受试者1－8（左侧）和9－16（右侧）在基线、1，3，6月的评估数据
改良Erickson交流方式量表（s－24）

说话者所经历口吃的全面评估（OASES）




结 论

    在使用思比易1月后的评估中，三种定性测量问卷都表现出相似的倾向性：从基线（使用设备前）开始，生活态度得分显著的陡降至更积极有利的水平，随后，得分保持此水平，某些病例又有所回升。与言语流利测量及定量得分相比较，显示出某些病例言语表现和态度方面测量无相关性；而其它病例在言语生成和感知测量中则有很好的一致性。当所有数据收集完整后，将进一步相关性检验。

19楼文章的图表没有转贴过来，可根据网址查阅原文

非常, 非常的感谢飞翔鸟 为我们翻译了这些思比易的资料!  难以言喻的感谢!