Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks

Last updated: February 11, 2025
Sponsor: Concordia University, Montreal
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Treatment

Cognitive-Behavioural therapy for insomnia (CBT-I)

Clinical Study ID

NCT04024787
30011416
  • Ages 25-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 neural processes underlying these daytime complaints may involve abnormal activation of brain regions and neural networks involved in working memory, memory encoding and emotions. The goal of this study is to assess whether a psychological treatment for insomnia will reverse these abnormalities in brain responses to cognitive tasks and at rest. A secondary objective of the study is to characterize impairments in attentional processing and assess if the impairments can be reversed by the psychological treatment. We hypothesized that the psychological treatment for insomnia will lead to a normalization of the brain responses to working memory, declarative memory encoding, insomnia-related stimuli, and the functional connectivity within the default-mode and limbic networks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

80 participants with chronic primary insomnia (40 per group) 40 good sleepers

Exclusion

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 3months or expecting to do so during the study period

  23. Severe mental disorders: bipolar disorder (Type I), schizophrenia, anxietydisorders, major depressive disorder, current substance use disorder, currentpost-traumatic stress disorder

  24. Current suicidality

  25. Frequent alcohol consumption (>10 glasses/week) or use of cannabis (more than once aweek) 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 firstassessment

  31. For good sleepers: insomnia symptoms more than 3 times/ week.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Cognitive-Behavioural therapy for insomnia (CBT-I)
Phase:
Study Start date:
July 30, 2019
Estimated Completion Date:
July 30, 2025

Study 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 chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger recovery in these brain responses, compared to a 3-month wait period.

Brain responses to emotional stimulation, especially to insomnia-related stimuli, will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in these brain responses, compared to a 3-month wait period.

Connectivity in the default-mode and limbic networks during resting-state will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in this connectivity, compared to a 3-month wait period.

Connect with a study center

  • Perform Center, Concordia University

    Montréal, Quebec H4B 1R6
    Canada

    Active - Recruiting

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