ClinConnect ClinConnect Logo
Search / Trial NCT04024787

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

Launched by CONCORDIA UNIVERSITY, MONTREAL · Jul 17, 2019

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a specific psychological treatment for chronic insomnia might improve brain activity and cognitive function in individuals who have difficulty sleeping. People with chronic insomnia often struggle to fall asleep and stay asleep, leading to problems with memory and attention during the day. The researchers want to see if the treatment can help normalize brain responses when participants are resting or completing tasks that require thinking, such as remembering information.

To participate in the study, individuals should be between 25 and 65 years old and have been diagnosed with chronic primary insomnia. Healthy sleepers are also needed for comparison. However, those with certain health conditions, past surgeries, or neurological disorders won't be eligible. Participants can expect to undergo brain scans and assessments to evaluate their sleep patterns and cognitive abilities before and after receiving the treatment. This trial is currently recruiting, so it’s a great opportunity for those who are struggling with insomnia to potentially improve their sleep and daily functioning.

Gender

ALL

Eligibility 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.

About Concordia University, Montreal

Concordia University, located in Montreal, is a leading institution dedicated to advancing research and innovation in various fields, including health sciences. As a prominent clinical trial sponsor, Concordia University leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at improving patient outcomes and enhancing healthcare practices. The university fosters collaborations with industry partners and healthcare professionals, ensuring that its clinical trials adhere to the highest ethical standards and scientific integrity, while contributing valuable insights to the global medical community.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Thanh Dang-Vu, MD PhD

Principal Investigator

Concordia University, Montreal

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials