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临床试验/ACTRN12619000549123
ACTRN12619000549123招募中未知

ocal Sleep” in the Awake Brain: An Underlying Cause of Neurobehavioural Deficits in Obstructive Sleep Apnea?

Woolcock Institute of Medical Research0 个研究点目标入组 32 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
32

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
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
35 Years 至 65 Years(—)
性别
All

入选标准

  • The participant's apnea-hypopnea index (AHI) must be greater than or equal to 15/hr to be eligible for the study. The symbol has been replaced with text below.
  • ____________________________
  • Males and females;
  • Community-dwelling aged 35-65 years;
  • Polysomnography confirmed moderate to severe OSA based on the apnea-hypopnea index (AHI) greater than or equal to 15/hr;
  • Able to give informed consent;
  • Fluent in English;
  • Established CPAP users for a duration of at least 3 months (on average 4 hours use per night on at least 5 nights per week)
  • Ability to perform neurobehavioural tests and driving simulator task.
  • Current driver’s license
  • Vulnerable to driving impairment without CPAP therapy/upon withdrawal of therapy, Assessed via positive response(s) to questions reporting driving accidents or impairments prior to established CPAP therapy, and/or physician's opinion.

排除标准

  • Clinically significant co-morbidity;
  • Major neurological problems (e.g. stroke, epilepsy, head injury);
  • Severe mental health disorder (e.g. current major depression, schizophrenia, bipolar disorder);
  • Regular use of sleep-affecting medication; benzodiazepines, opioids, antidepressants.
  • Shift worker or have traveled overseas within the last 2 weeks.
  • Professional drivers.
  • Sleep physician has advised against CPAP withdrawal

研究者

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