ACTRN12612001136897招募中未知
In participants with Obstructive Sleep Apnoea (OSA) and depression, is Continuous Positive Airway Pressure (CPAP) effective in reducing the symptoms associated with depression?
ational Health and Medical Research Council Australia0 个研究点目标入组 360 人开始时间: 2012年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 360
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •Apnoea/hypopnoea index (AHI) greater than 15
排除标准
- •Central (non-obstructive) sleep apnoea.
- •Current or prior treatment for OSA, including: mandibular advancement splint; CPAP therapy; upper airway surgery; Provent Nasal Device (microvalve technology that provides expiratory positive airway pressure).
- •Participants who meet the DSM-IV diagnostic criteria for psychotic symptoms as assessed by the SCID Psychotic Screen modules B/C; or participants who meet the DSM-IV diagnostic criteria for substance abuse or co-morbid alcohol use as diagnosed by the SCID Substance Use Disorders module E,
- •within the 12 months prior to enrolment.
- •Participants who are actively suicidal as assessed by the Columbia Suicide Severity Rating Scale.
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The study aims to confirm the effectiveness and safety of BF2.649 by comparing it with a placebo (a pharmacologically inactive product) for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea treated by nCPAP.Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS)MedDRA version: 14.1Level: LLTClassification code 10015595Term: Excessive daytime sleepinessSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-017248-14-SEBIOPROJET280
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