ACTRN12619000549123招募中未知
ocal Sleep” in the Awake Brain: An Underlying Cause of Neurobehavioural Deficits in Obstructive Sleep Apnea?
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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