NCT01553383已完成不适用
Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for OSA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve "Provent" in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.
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
- •Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI > 10/hr)
- •Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA.
- •Able to sign informed consent and use the PEEP nasal valve.
- •Age between 18-65 years old.
- •Willing to attend follow up.
排除标准
- •Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve.
- •Unable to sign consent or use PEEP nasal valve.
- •Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority.
- •Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 1 month
次要结局
- side effects as a measure of tolerability(1 month)
研究者
To Kin Wang
Associate consultant
Chinese University of Hong Kong
研究点 (1)
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