Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-12; most recent amendment 2025-04-05.
Status change: Not Yet Recruiting → Recruiting 2025-04-05
Trial Details
NCT Number NCT06779149
Lead Sponsor Laval University
Collaborators: Toronto Metropolitan University, The Royal Ottawa Mental Health Centre
Conditions Insomnia Disorder
Enrollment 90 participants
Start Date 2025-04-01
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-04-09