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临床试验/NCT02613975
NCT02613975已完成不适用

A Cross Over Case Control Study Using a Vibration Positional Device for Treatment of Position Dependent Obstructive Sleep Apnea

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Reduction of AHI using the positional device

研究概览

简要总结

Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Positional OSA is present when the overall apnea hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group 1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will be provided with a vibration device as treatment, which will be worn on the neck during sleep. This device senses the position of the patient during sleep. It will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of OSA. It will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. There will be a wash out period of 1 week in between the on and off period to remove any residual effect. Group 2 consists of patients with positional OSA who are using dental device but response or tolerated poorly. They will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. The device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. Informed consent will be signed. Each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with position dependent OSA which is defined as supine AHI >2 times the AHI in other positions, while an overall AHI >5/hr.
  • Patients who cannot tolerate/not using CPAP.
  • Patients who are on dental devices but residual AHI is > 15 and symptomatic.
  • Patients consent to study and able to follow the instruction of using positional device and home sleep study device.

排除标准

  • Patients with pregnancy.
  • Patients who refuse home sleep studies.
  • Patients with parasomnias.
  • Patients who cannot follow the instruction of using positional device or home sleep study device.
  • Patients who tolerate CPAP well with good treatment outcome.
  • Patients on dental device with good symptoms improvement and residual AHI < 15/hr

结局指标

主要结局

Reduction of AHI using the positional device

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

To Kin Wang

Doctor

Chinese University of Hong Kong

研究点 (1)

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