NCT01466309Unknown不适用
The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea index
研究概览
简要总结
Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.
详细描述
Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age > 18 years with OSA
- •Refused CPAP therapy
排除标准
- •Poor oral hygiene
- •Untreated TMD
- •Inadequate healthy teeth (< 6)
- •Severe or unstable medical problems.
结局指标
主要结局
Apnea-Hypopnea index
时间窗: 1 year
次要结局
- Number of Participants with Adverse Events"(1 year)
研究者
研究点 (2)
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