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RECRUITING

NCT06779149

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

Sponsor: Laval University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2027-02

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Insomnia Disorder

Interventions

BEHAVIORAL

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Participants in this treatment group will receive CBT-I. CBT-I sessions will occur weekly for the first 4 sessions and biweekly for the last 2 sessions (treatment phase is thus 8 weeks). : Graduate level students in clinical psychology will serve as therapists for this project.

DRUG

Lemborexant

Participants assigned to this group will be prescribed 5 to 10 mg of lemborexant to be taken at bedtime in 5 mg capsules. Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.

DRUG

Placebo

Participants assigned to this group will be prescribed 5 to 10 mg of placebo to be taken at bedtime in 5 mg capsules identical to lemborexant. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.

Inclusion Criteria: * 18 years of age or older at the time of enrolment * Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder (Duke Sleep Interview), with total Insomnia Severity Index (ISI) score \> 10, and score ≥ 2 on either the interference or distress item * Minimal symptoms of anxiety and/or depression with Patient Health Questionnaire (PHQ-9) \> 4 and/or Generalized Anxiety Disorder (GAD-7) \> 4 * Ability to read and understand French or English * Ability to use a smartphone, tablet, or computer, and access to home internet connection Exclusion Criteria: * Presence of a lifetime diagnosis of any psychotic or bipolar disorder * Untreated psychiatric disorder (e.g., major depression) or risk for suicide * Substance/alcohol use disorder within the past year * Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia) * Current use of sleep-promoting medications (prescribed or over-the-counter) or cannabis-derived products for sleep more than two nights per week * Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants * Reported diagnosis of sleep disorder other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, rapid eye movement behavior disorder, delayed phase sleep disorder, narcolepsy) * Total score \> 5 on the Stop-Bang Questionnaire and/or clinical symptoms suggestive of sleep apnea (excessive daytime sleepiness), or Epworth score \> 10, restless legs syndrome or other signs of other sleep disorders * Atypical sleep schedules (i.e., habitual bedtimes later than 2:00 AM and rising times later than 10:00 AM on more than two days/nights per week as documented from a sleep diary) * Working night shifts more than five nights per month in the last six months * Consuming 2 or more alcoholic beverages per day regularly (3 days or more per week) * Any contra-indications to using the study medication, including lung disease/breathing problems (e.g., chronic obstructive pulmonary disease), use of strong or moderate CYP3A inducers (strong - rifampin, carbamazepine, and St. John's Wort) (moderate - bosentan, efavirenz, etravirine, and modafinil), pregnant and breastfeeding women * Not using any method of birth control

Locations (1)

Université Laval Centre d'étude des troubles du sommeil

Québec, Quebec, Canada