Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change in AHI (apnea-hypopnea index) on polygraphy
研究概览
简要总结
This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity.
详细描述
This is a randomized controlled study. Participants with moderate OSAS severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). Apnea-hypopnea index (AHI) will be measured before and at the end (6 weeks) of the protocol. Participants from the study group will follow an upper airway reinforcement regimen using the IOPI (Iowa Oral Performance Instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
- •Poor adherence to continuous positive airway pressure (< 4h per night)
排除标准
- •Craniofacial malformation
- •Use of hypnotic medication
- •Had stroke in the past
- •Present a concurrent neuromuscular or severe obstructive nasal disease
研究组 & 干预措施
Study Group
Participants from the study group will follow an upper airway reinforcement regimen using the IOPI device over 6 weeks. The reinforcement protocol will be adapted each week to improve Percentage of initial strength Exercises will be adapted each week
干预措施: IOPI (Device)
Control group
Participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance. The expiratory pressure will remain unchanged over the weeks.
干预措施: EMT threshold (Device)
结局指标
主要结局
Change in AHI (apnea-hypopnea index) on polygraphy
时间窗: Baseline and 6 weeks
Evolution of the number of apnea-hypopnea events (AHI) over 6 weeks. The AHI value at discharge will be compared with the baseline value.
次要结局
- Change in tongue strength using the IOPI device(Baseline and 6 weeks)
- Change in tongue endurance using the IOPI device(Baseline and 6 weeks)
研究者
Olivier Contal
Principal Investigator
Haute Ecole de Santé Vaud