Status:
RECRUITING
Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks
Lead Sponsor:
Concordia University, Montreal
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Chronic Insomnia
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of altered daytime functioning that may be associated with cognitive impairments. The neu...
Detailed Description
Study hypothesis Brain responses associated with working memory task and declarative memory encoding will be decreased in chronic insomnia compared to good sleepers and, among individuals with chroni...
Eligibility Criteria
Inclusion
- 80 participants with chronic primary insomnia (40 per group) 40 good sleepers
Exclusion
- Older than 65 y.o. or younger than 25 y.o.
- Contraindication to the MRI scanning
- Current neurological disorder
- Past history of brain lesion
- Major surgery (i.e., requiring general anesthesia) in the past 3 months
- Untreated thyroid disorder
- Chronic pain syndrome self-reported as interfering with sleep
- Recent and severe infection in the past 3 months
- Active cancer, or remitted cancer with cancer treatment within the last 2 years
- Stroke
- Myocardial infarct
- Arterial bypass or angioplasty
- Pacemaker
- Heart failure causing limitation of ordinary physical activity
- Renal insufficiency
- Sleep apnea with an apnea-hypopnea index \> 5/h
- Restless legs syndrome with symptoms 3 days or more per week
- Periodic limb movements during sleep with index \> 15/h
- REM-sleep behavior disorder
- Narcolepsy and other central disorders of hypersomnolence
- Sleepwalking more than once/month
- 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
- Severe mental disorders: bipolar disorder (Type I), schizophrenia, anxiety disorders, major depressive disorder, current substance use disorder, current post-traumatic stress disorder
- Current suicidality
- Frequent alcohol consumption (\>10 glasses/week) or use of cannabis (more than once a week) or illicit drugs (more than once a month)
- Smoking cigarettes more than 10 cigarettes/day
- Pregnant or breastfeeding women
- Current psychotherapy or past cognitive-behavioural therapy for insomnia
- Current use of medication for depression or anxiety
- Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment
- For good sleepers: insomnia symptoms more than 3 times/ week.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04024787
Start Date
July 30 2019
End Date
July 30 2025
Last Update
February 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Perform Center, Concordia University
Montreal, Quebec, Canada, H4B 1R6