Actively Recruiting
Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
Led by Laval University · Updated on 2025-04-09
90
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
T
Toronto Metropolitan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of enrolment
- Meet DSM-5 criteria for insomnia disorder with Insomnia Severity Index score above 10 and significant interference or distress
- Minimal symptoms of anxiety or depression with PHQ-9 score above 4 and/or GAD-7 score above 4
- Ability to read and understand French or English
- Ability to use a smartphone, tablet, or computer and have access to home internet connection
You will not qualify if you...
- Lifetime diagnosis of any psychotic or bipolar disorder
- Untreated psychiatric disorders or risk of suicide
- Substance or alcohol use disorder within the past year
- Any life-threatening or progressive medical illness or neurological degenerative disease
- Current use of sleep-promoting medications or cannabis-derived products more than two nights per week
- Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants
- Diagnosis of sleep disorders other than insomnia
- High risk or symptoms of sleep apnea or restless legs syndrome
- Atypical sleep schedules with late bedtimes and wake times more than two nights per week
- Working night shifts more than five nights per month in the last six months
- Regular consumption of two or more alcoholic drinks per day on three or more days per week
- Contraindications to study medication, including lung or breathing problems, use of strong or moderate CYP3A inducers, pregnancy, or breastfeeding
- Not using any method of birth control
AI-Screening
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Trial Site Locations
Total: 1 location
1
Université Laval Centre d'étude des troubles du sommeil
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
Research Team
M
Manon Lamy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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