Cognitive behavioural therapy combined with exercise training for adults with both insomnia and obstructive sleep apnea
- Conditions
- Treatment for comorbid chronic insomnia and obstructive sleep apnea.Nervous System Diseases
- Registration Number
- ISRCTN63989489
- Lead Sponsor
- Concordia University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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).
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
9. Stroke
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia severity is assessed using the Insomnia Severity Index (ISI) questionnaire at baseline, following phase 1 (8 weeks) and following phase 2 (16 weeks)
- Secondary Outcome Measures
Name Time Method <br> 1. Peak oxygen consumption (VO2 peak) during a symptom-limited cardiopulmonary exercise test on a cycle ergometer conducted at pre-treatment, mid-treatment (8 weeks), and post-treatment (16 weeks).<br> 2. Oxygen desaturation index during the overnight polysomnography conducted at pre-treatment, mid-treatment, and post-treatment.<br> 3. Cumulative time spent below 90% SpO2 during the overnight polysomnography conducted at pre-treatment, mid-treatment, and post-treatment.<br> 4. Sleep efficiency (i.e. the ratio of total sleep time overtime over the time spent in bed) during overnight polysomnography at pre-treatment, mid-treatment, and post-treatment.<br> 5. Body mass index (BMI; kg/m²) measured at pre-treatment, mid-treatment, and post-treatment.<br>