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Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2025 to Apr 1, 2025
    v3
  2. Secondary endpoints: details revised at 2 of 10 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.
Trial Details
NCT Number NCT06779149
Lead Sponsor Laval University
Collaborators: Toronto Metropolitan University, The Royal Ottawa Mental Health Centre
Conditions
(from sponsor)		 Insomnia Disorder
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov