Search / Trial NCT06615336

Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia

Launched by LAVAL UNIVERSITY · Sep 24, 2024

Trial Information

Current as of October 08, 2024

Completed

Keywords

Chronic Insomnia Intensive Sleep Retraining Total Sleep Deprivation

Description

The pre-treatment period consisted of two consecutive weeks and was scheduled from Thursday to Thursday to coordinate the treatment period over the weekends. At the end of the pre-treatment period, participants were informed of their assignment to one of the three conditions. Participants were required to report to the sleep laboratory on Thursday at 7:00 p.m. for the night. Their time in bed was restricted to 6.5 hours (11:00 p.m. to 5:30 a.m.) to increase homeostatic sleep pressure before treatment. After waking up, participants were asked to leave the laboratory and could attend their no...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Age between 18 and 60 years old;
  • * Diagnosis of chronic insomnia based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria;
  • * Sleep onset latency ≥ 30 minutes for ≥ 3 nights per week for 2 weeks as measured by a daily sleep diary;
  • * Sleep efficiency ≤ 85% for 2 weeks as measured by a sleep diary;
  • * Significant distress or impairment of daytime functioning (score of at least 2 on item 5 or 7 of the Insomnia Severity Index);
  • * Have access to a computer with an Internet connection to complete questionnaires.
  • Exclusion Criteria:
  • * Active or unstable progressive medical condition (e.g., cancer) or degenerative neurological disease (e.g., dementia);
  • * Current diagnosis of major depression, dysthymia or anxiety disorders;
  • * Lifetime diagnosis of any psychotic or bipolar disorder;
  • * Other sleep disorders, sleep apnea (apnea/hypopnea index greater than 15) restless legs, or periodic limb movements during sleep (movement index with arousal greater than 15 per hour);
  • * Alcohol or substance use disorder in the past 12 months;
  • * Use of any drug known to affect sleep (e.g., cocaine) in the past 2 weeks;
  • * Current or planned pregnancy during the study;
  • * Night shift work or irregular sleep pattern (e.g., usual bedtime after 2:00 a.m. or usual wake time after 10:00 a.m.);
  • * Current suicidal risk;
  • * Body mass index greater than 32;
  • * Use of sleep-inducing drugs (prescription or non-prescription);
  • * Use of tobacco products.

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Québec, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0