ISRCTN63989489已完成未知
A pilot randomized trial of combined cognitive behavioural therapy & exercise training versus exercise training alone for the treatment of co-morbid insomnia disorder and obstructive sleep apnea.
Concordia University0 个研究点目标入组 20 人开始时间: 2022年4月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Meeting diagnostic criteria for a DSM-5 insomnia disorder.
- •2. Diagnosed with mild to moderate obstructive sleep apnea (AHI 30/h during baseline polysomnography).
排除标准
- •1. Younger than 18 years old
- •2. Current neurological disorder
- •3. Past history of brain lesion
- •4. Major surgery (i.e., requiring general anesthesia) in the past 3 months
- •5. Untreated thyroid disorder
- •6. Chronic pain syndrome self-reported as interfering with sleep
- •7. Recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection)
- •8. Active cancer or treated cancer with post-cancer treatment for less than 2 years
- •10. Myocardial infarct
- •11. Arterial bypass or angioplasty (coronary, carotid, femoral, etc)
- •12. Use of a pacemaker
- •13. Heart failure causing limitation of ordinary physical activity
- •14. Renal insufficiency
- •15. Restless legs syndrome with symptoms 3 days or more per week (based on RLS questionnaire)
- •16. Periodic limb movements during sleep with index > 15/h during polysomnography
- •17. REM-sleep behavior disorder with more than 1 episode/month (based on screening questionnaire and PSG)
- •18. Narcolepsy with cataplexy
- •19. Sleepwalking more than once per month
- •20. Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months or expecting to do so during the study period
- •21. Poor cognitive function (diagnosed dementia and/or MOCA less than 26)
- •22. Severe mental disorders:
- •22.1 Bipolar disorder (Type I)
- •22.2 Schizophrenia past or anxiety disorder
- •22.3 Anxiety disorders other than GAD if not associated with MDD: Exclude.
- •22.4 Current Substance use disorder
- •22.5 Current post-traumatic stress disorder
- •23. Current Suicidality
- •24. Frequent alcohol consumption (>10 glasses/week) or use of illicit drugs (more than once a month)
- •25. Pregnant or breastfeeding women
- •26. Current psychotherapy or past CBTi
- •27. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment (e.g., benzodiazepines, zolpidem, zopiclone, quetiapine, antihistamines)
- •28. Currently engaging in moderate or vigorous physical activity for over 150 minutes per week.
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