DRKS00033048尚未招募Unknown
Sleep position therapy for mild to moderate position-dependent obstructive sleep apnea - POSA
ehrstuhl für Medizinmanagement, Universität Duisburg-Essen0 个研究点目标入组 440 人开始时间: 2024年6月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •mild to moderate, supine-dependent obstructive sleep apnoea (total AHI 5 - < 30/h)
- •- AHI at least twice as high in supine position compared to non-supine position
- •- at least 30% of total sleep time in supine position
- •- AHI in non-supine position < 10/h
- •- Indication for nocturnal positive pressure therapy with relevant daytime sleepiness (ESS > 10 points)
排除标准
- •- previous or current treatment for sleep apnoea with devices or surgery
- •- current oxygen therapy
- •- current pregnancy
- •- active employment as a professional driver
- •- taking sedative or vigilance-enhancing medication
- •- unstable medical condition that, in the opinion of the investigator, may interfere with participation in the study
- •- presence of other relevant sleep disorders affecting daytime sleepiness
- •- excessive alcohol consumption (> 3 drinks/day)
- •- drug use
- •- severe claustrophobia
- •- musculoskeletal problems that limit sleeping in a lateral position
- •- inability to understand the study and patient information leaflet
- •- Patients with an active, cardiac device (pacemaker, ACID, CRT, ...)
- •- use of other medical devices (e.g. implanted aggregates, neurostimulation devices, or similar) that may be affected by the mild vibration stimuli to the chest from the sleep position trainer
- •- health condition that requires sleeping in the supine position (e.g. due to shoulder or back surgery or osteoarthritis)
- •- sleeping in an upright position (e.g. due to the use of more than two pillows)
研究者
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