Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Will not be known if participant is getting the actual device or using the placebo
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 50
- •Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
- •Body mass index < 30 kg/m2
- •Mild to moderate OSA, AHI of 5-30
排除标准
- •Apnea hypopnea index on overnight sleep study > 30 per hour
- •Currently practices didgeridoo
- •Consumes more than 2 alcoholic beverages per day
- •History of chronic lung disease (e.g., COPD, asthma)
- •Oral maxillofacial issue or craniofacial musculoskeletal conditions
- •Any treatment for OSA (current or past)
- •Mobile device use frequency < once per week
- •Homelessness
- •No reliable transportation to assessment sessions
- •Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
- •Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
- •Uncorrected low vision or blindness
- •No Internet connection/Chrome browser/mobile devices with iOS and Android
- •No USB port in computer
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 8-12 weeks
Apnea Hypopnea Index during sleep
次要结局
未报告次要终点
研究者
Clete A. Kushida
Division Chief/Medical Director
Stanford University