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临床试验/DRKS00033048
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

发起方
ehrstuhl für Medizinmanagement, Universität Duisburg-Essen

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