Impact of Muscle Training Device on Non-Severe OSA: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change of apnea event after DidgeriTU usage compared with sham device
研究概览
简要总结
The goal of this clinical trial is to test for the efficacy of the newly invented device #DidgeriTU with non-severe obstructive sleep apnea. The main question it aims to answer is:
• Can DidgeriTU reduce apnea events in patients with non-severe obstructive sleep apnea? Researchers will compare DidgeriTU with a sham device to see how the apnea event has changed.
Participants will:
- Use DidgeriTU or sham device for 3 month
- Do an online questionnaire once a month during the study
- Home sleep test, lung function test, and tongue strength test at the start and end of the study
详细描述
Previously, in Switzerland, an aboriginal musical instrument, the Didgeridoo, was taught to patients with OSA. It has been proven to be effective in reducing apnea events.
Our newly invented instrument, DidgeriTU, adopts the Didgeridoo principle for expiratory muscle exercise to reduce apnea events.
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
- •Patients diagnosed with mild to moderate obstructive sleep apnea.
- •Age 18 years or older.
- •Patients voluntarily consent to provide information for research purposes.
排除标准
- •Patients with an average apnea-hypopnea index (AHI) of <4 or >29 events per hour after repeated diagnosis using a home sleep apnea test.
- •Patients who refused to cease using CPAP during the study process
- •Patients with a history of chronic lung disease.
- •Elderly patients with neurological conditions that impair cognitive function, such as dementia, stroke, or psychiatric disorders.
- •Patients taking medications that may affect muscle function within 3 months before the start of the study.
- •Patients with hypothyroidism or other conditions that may affect muscle function.
- •Patients who consume alcohol at a moderate level or higher
结局指标
主要结局
Change of apnea event after DidgeriTU usage compared with sham device
时间窗: 3 months
Participants with a known history of non-severe obstructive sleep apnea will repeat the home sleep apnea test. The study will include patients with non-severe OSA(Apnea-hypopnea index 5-29/hr) from HSAT. After the usage of DidgeriTU or sham device for 3 months, the participant will repeat HSAT to explore the change of AHI after DidgeriTU use compared with sham device.
次要结局
- Change of OSA severity after the usage of DidgeriTU comparing with sham device(3 months)
- Change in Epworth sleepiness scale after the usage of DidgeriTU comparing with sham device(3 months)
- Change of maximum inspiratory pressure; MIP after DidgeriTU usage comparing with sham device(3 months)
- Change of maximum expiratory mouth pressure; MEP after DidgeriTU usage comparing with sham device(3 months)
- change in Pittsburg Sleep Quality Index; PSQI after DidgeriTU usage comparing with sham device(3 months)
- Change of snoring frequency after DidgeriTU usage compared with a sham device(3 months)
- change of oxygenation during sleep after DidgeriTU usage comparing with sham device(3 months)
研究者
Naphitchaya Wiriya
Naphitchaya Wiriya, MD.
Thammasat University