Effects of insomnia treatment on brain activity and cognitive function
Neural Responses and Connectivity During Rest, Memory Encoding and Emotional Stimulation in Chronic Insomnia, and Their Relationships With Insomnia Treatment: a Wait-list Controlled Randomized Trial of Cognitive-behavioural Therapy for Insomnia
This study tests if cognitive-behavioral therapy for insomnia can help people with chronic insomnia improve their brain activity and thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Concordia University, Montreal Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT04024787 on ClinicalTrials.gov |
What this trial studies
This study investigates how cognitive-behavioral therapy for insomnia (CBT-I) affects brain responses during cognitive tasks and at rest in individuals with chronic insomnia. It aims to determine if CBT-I can normalize abnormal brain activation patterns and improve cognitive impairments associated with insomnia. Participants will be compared to good sleepers to assess differences in brain responses and connectivity in specific neural networks. The study will also evaluate attentional processing impairments and their potential reversal through treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25 to 65 who have been diagnosed with chronic primary insomnia.
Not a fit: Patients with significant neurological disorders, sleep apnea, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients suffering from chronic insomnia.
How similar studies have performed: Previous studies have shown promising results for cognitive-behavioral therapy in treating insomnia, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 80 participants with chronic primary insomnia (40 per group) 40 good sleepers Exclusion Criteria: 1. Older than 65 y.o. or younger than 25 y.o. 2. Contraindication to the MRI scanning 3. Current neurological disorder 4. Past history of brain lesion 5. Major surgery (i.e., requiring general anesthesia) in the past 3 months 6. Untreated thyroid disorder 7. Chronic pain syndrome self-reported as interfering with sleep 8. Recent and severe infection in the past 3 months 9. Active cancer, or remitted cancer with cancer treatment within the last 2 years 10. Stroke 11. Myocardial infarct 12. Arterial bypass or angioplasty 13. Pacemaker 14. Heart failure causing limitation of ordinary physical activity 15. Renal insufficiency 16. Sleep apnea with an apnea-hypopnea index \> 5/h 17. Restless legs syndrome with symptoms 3 days or more per week 18. Periodic limb movements during sleep with index \> 15/h 19. REM-sleep behavior disorder 20. Narcolepsy and other central disorders of hypersomnolence 21. Sleepwalking more than once/month 22. 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 23. Severe mental disorders: bipolar disorder (Type I), schizophrenia, anxiety disorders, major depressive disorder, current substance use disorder, current post-traumatic stress disorder 24. Current suicidality 25. Frequent alcohol consumption (\>10 glasses/week) or use of cannabis (more than once a week) or illicit drugs (more than once a month) 26. Smoking cigarettes more than 10 cigarettes/day 27. Pregnant or breastfeeding women 28. Current psychotherapy or past cognitive-behavioural therapy for insomnia 29. Current use of medication for depression or anxiety 30. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment 31. For good sleepers: insomnia symptoms more than 3 times/ week.
Where this trial is running
Montréal, Quebec
- Perform Center, Concordia University — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Thanh Dang-Vu, MD PhD — Concordia University, Montreal
- Study coordinator: Thanh Dang-Vu, MD PhD
- Email: tt.dangvu@concordia.ca
- Phone: 514-848-2424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.