A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- apnea-hypopnea index (AHI)
研究概览
简要总结
The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.
详细描述
The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •OSA patients aged over 18 years old at Siriraj hospital
- •Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI > 30 events/h but lowest Oxygen saturation > 70%
- •Positive consented form
排除标准
- •Patients with severe periodontal diseases
- •Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
- •total sleep time less than 2 hour during previous sleep study
- •Patients who could not tolerate the side effects of CPAP or TRD
- •Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
结局指标
主要结局
apnea-hypopnea index (AHI)
时间窗: 3 weeks
次要结局
- satisfaction and preference of device questionnaire(3 weeks)
- Functional outcomes of sleep questionnaire (FOSQ ) score(3 weeks)
- Epworth sleepiness score (ESS) scores(3 weeks)
- lowest oxygen saturation during sleep test at home(3 weeks)
- side effects questionnaire(3 weeks)