A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 2 weeks and Wash-out periods 2 weeks 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 YO at Siriraj hospital
- •AHI 5 - 30 events/ h or AHI > 30 events/h but lowest O2 saturation > 70%
- •Positive consented form
排除标准
- •Patients with severe Temporomandibular joint diseases or limited mandible advancement (< 5 mm)
- •Patients with severe periodontal diseases or inadequate teeth (< 3 teeth in each quadrant)
- •Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
- •Patients who could not tolerate the side effects of CPAP or SMG
- •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
Quality of life
时间窗: 6 weeks
FOSQ scores
次要结局
- side effects(6 weeks)
- satisfaction(6 weeks)
- AHI(6 weeks)
- Degree of sleepiness(6 weeks)
- lowest oxygen saturation(6 weeks)
研究者
WISH BANHIRAN
Associate Professor
Mahidol University