轻度阻塞性睡眠呼吸暂停综合征难治性高血压患者言语治疗的有效性
2018年11月21日 更新者：Alessandra Bastos de Sousa、Universidade Federal do Rio de Janeiro
本研究的目的是分析言语治疗对患有轻度阻塞性呼吸暂停综合征的高血压患者的生活质量、睡眠质量、日间嗜睡水平和呼吸暂停低通气指数的影响。
研究概览
详细说明
该数据库将包括人口统计学特征、心血管危险因素和靶器官损害。
将记录人体测量数据（身高、体重、腹围和颈围）。
日间嗜睡、睡眠质量和生活质量将通过相应的问卷进行评估：Epworth 嗜睡量表、匹兹堡睡眠质量指数 (PSQI) 和 SF-36。
为了评估气道，除了 Guimarães (2009) 的改编评估方案外，还将使用 Mallampati 等级。
最终分数与基线分数之间的差异将根据所应用的每份问卷中的基线值进行计算和调整。
最后，将重做排除与对照组相比言语治疗依从性不佳（低于 85%）的患者的分析。
如果言语治疗有疗效，也会在临床试验结束后提供给对照组。
统计分析将在统计包 SPSS version 19.0 package (SPSS Inc.
美国伊利诺伊州芝加哥）。
获得的数据可能对未来的患者有益，将仅用于统计目的。
所收集信息的保密性将得到保证，从而确保信息的私密性和保密性。
此外，所获得的数据不会用于协议未预见的其他目的。
研究类型
介入性
注册 (预期的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rio de Janeiro、巴西、21941-913
- Hospital Universitario Clementino Fraga Filho
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 在 Hospital Universitário Clementino Fraga Filho - UFRJ 接受高血压计划 (ProHart) 随访至少六个月的患者；
- 通过多导睡眠图检测到患有顽固性高血压和轻度阻塞性睡眠呼吸暂停的患者；
- 所有给予书面知情同意的参与者。
排除标准：
- 年龄＞85岁；
- 妨碍言语治疗的认知缺陷；
- 最近 6 个月内的严重临床事件；
- 患者拒绝参加研究；
- 怀孕;
- 之前和经常使用 CPAP；
- 提示神经系统疾病伴认知和/或运动后遗症、颅面畸形、严重上呼吸道阻塞、神经肌肉疾病、安眠药使用者的临床数据
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：言语治疗组
25 名患者将接受言语治疗，每周一次，每次 40 分钟，持续 12 周。
口咽练习将在言语治疗师的监督下进行。
患者将每天在家中进行口咽锻炼。
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口咽练习将在言语治疗师的监督下进行。
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假比较器：控制组
25 名患者将进行吸气和呼气练习，以募集膈肌。
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吸气和呼气练习募集膈肌
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Epworth 嗜睡量表的变化
大体时间：五个月
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对照组和言语治疗组在 12 周后发现得分变化。
ESS 测量 EDS 水平，根据在每种提到的情况下睡觉的可能性分配一个分数（从 0 到 3）。
从 0 到 6 的分数被认为是正常的；从 7 到 9，limitrophe； 10到14，轻度嗜睡； 15至20，中度嗜睡；及以上，严重嗜睡。
值≥11 通常与睡眠障碍有关。
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五个月
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SF-36 的变化
大体时间：五个月
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对照组和言语治疗组在 12 周后发现得分变化。
SF-36 由 36 个项目组成，分为八个领域：功能能力、身体方面、疼痛、一般健康状况、活力、社交方面、情感方面和心理健康。
它评估消极（疾病或疾病）和积极方面（幸福），分数从 0 到 100，0 表示最差的健康状况，100 表示最好，每个维度分别进行分析。
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五个月
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匹兹堡睡眠质量指数 (PSQI) 的变化
大体时间：五个月
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对照组和言语治疗组在 12 周后发现得分变化。
O questionário de Pittsburgh permite avaliar o sono de forma qualitativa e quantitativa, de forma padronizada, ao determinar os "bons dormidores" e "maus dormidores"。
O questionário avalia parâmetros quantitativos, tais como a duração do sono, latência do sono e número de despertares; e parâmetros qualitativos，que são puramente subjetivos。
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五个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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呼吸暂停低通气指数
大体时间：初始临床评估后三个月
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在合格专业人员的监督下，使用 BrainNet BNT Polipolygraph 对患者进行多导睡眠监测。
实现了脑电图、眼电图、颏下肌电图、鼻腔气流、血氧饱和度、呼吸努力、心电图和胫前肌电图。
考试辅以视频监控。
夜间睡眠时间少于 240 分钟的患者被排除在外。该报告由合格的医学专家、睡眠医学专家和在该地区持有执业证书的人编写，该人员不知情；临床数据，根据美国睡眠医学学会手册中制定的规范。
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初始临床评估后三个月
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言语治疗评估的定性评估
大体时间：四个月
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治疗组言语治疗后和对照组初始评估后 12 周后口面部肌功能的变化。
数据是从 oromiofunctional speech-language 评估协议中收集的，包括面部评估（眼睛、鼻孔、嘴唇、脸颊、下巴、舌头和上颚）和功能（呼吸、咀嚼和言语）。
通过改良的 Mallampati 分类评估的 UAW 身体状况，根据软腭和舌体与咽后壁之间的空间关系以及面纱和喉咽的狭窄（1 级，整个腭咽面纱和悬雍垂是可视化；2 级，悬雍垂和腭咽面纱弓部分可视化；3 级，悬雍垂或腭咽面纱未可视化；4 级，所有软腭均未可视化）。
人体测量：身高和体重计算BMI、颈围（大于41厘米 - 女性 - 大于43厘米 - 男性）和腰围。
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四个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alessandra B de Sousa、Universidade Federal do Rio de Janeiro
- 学习椅：Mariana P Brendim, Master、Universidade Federal do Rio de Janeiro
- 研究主任：Elizabeth S Muxfeldt、Universidade Federal do Rio de Janeiro
出版物和有用的链接
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- Pitta BDS, Pessoa AF, Sampaio ALL, et al. Terapia miofuncional oral aplicada a dois casos de síndrome da apneia obstrutiva do sono grave. Arq Int Otorrinolaringol; 2007;3:350-4. Disponível em: <http://www.arquivosdeorl.org.br/conteudo/acervo_port.asp?Id=452.
- Ryan CM, Bradley TD. Pathogenesis of obstructive sleep apnea. J Appl Physiol (1985). 2005 Dec;99(6):2440-50. doi: 10.1152/japplphysiol.00772.2005.
- Somers VK, White DP, Amin R, Abraham WT, Costa F, Culebras A, Daniels S, Floras JS, Hunt CE, Olson LJ, Pickering TG, Russell R, Woo M, Young T. Sleep apnea and cardiovascular disease: an American Heart Association/American College of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. J Am Coll Cardiol. 2008 Aug 19;52(8):686-717. doi: 10.1016/j.jacc.2008.05.002. No abstract available.
- Tufik S, Santos-Silva R, Taddei JA, Bittencourt LR. Obstructive sleep apnea syndrome in the Sao Paulo Epidemiologic Sleep Study. Sleep Med. 2010 May;11(5):441-6. doi: 10.1016/j.sleep.2009.10.005. Epub 2010 Apr 1.
- Zancanella E, Haddad FM, Oliveira LAMP, et al. Apneia Obstrutiva do Sono e Ronco Primário: Diagnóstico. Projeto Diretrizes. Associação Médica Brasileira e Conselho Federal de Medicina; 2012. Disponível em: <http://www.projetodiretrizes.org.br/diretrizes12/apneia_obstrutiva_do_sono_e_ronco_primario_diagnostico.pdf>.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月1日
初级完成 (预期的)
2019年12月1日
研究完成 (预期的)
2019年12月1日
研究注册日期
首次提交
2017年1月26日
首先提交符合 QC 标准的
2018年11月21日
首次发布 (实际的)
2018年11月27日
研究记录更新
最后更新发布 (实际的)
2018年11月27日
上次提交的符合 QC 标准的更新
2018年11月21日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
言语治疗的临床试验
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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Abbott Medical Devices完全的