Treatment for comorbid chronic insomnia and obstructive sleep apnea. Nervous System Diseases
Conditions
Interventions
This study is a 16-week randomized controlled trial. Participants are randomized to receive either relaxation therapy for eight weeks followed by a combination of cognitive-behavioural therapy for ins
Sponsors
Concordia University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). 2. Oxygen desaturation index during the overnight polysomnography conducted at pre-treatment, mid-treatment, and post-treatment. 3. Cumulative time spent below 90% SpO2 during the overnight polysomnography conducted at pre-treatment, mid-treatment, and post-treatment. 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. 5. Body mass index (BMI; kg/m²) measured at pre-treatment, mid-treatment, and post-treatment. | — |
Countries
Canada
Outcome results
None listed