NCT06779149

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Apr 2025Feb 2027

First Submitted

Initial submission to the registry

January 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

January 12, 2025

Last Update Submit

April 5, 2025

Conditions

Insomnia Disorder

Keywords

InsomniaCognitive behavioral therapy for insomniaLemborexantInsomnia phenotypesObjective short sleep duration

Outcome Measures

Primary Outcomes (1)

  • Insomnia Symptom Severity

    Insomnia symptoms will be measured by the Insomnia Severity Index (ISI). The ISI is a self-report questionnaire evaluating seven dimensions of insomnia-severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28, with a higher total score suggesting more severe insomnia symptoms. An ISI score \< 8 will be used to define remission. Treatment response will be defined at each assessment as a reduction of 8 points or more on the ISI compared with the baseline score.

    Baseline, during treatment period (weeks 0-8), at the end of the 2-week post-treatment and 6-month follow-up.

Secondary Outcomes (10)

  • Sleep onset latency from sleep diary

    Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.

  • Wake after sleep onset from sleep diary

    Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.

  • Total sleep time from sleep diary

    Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.

  • Sleep efficiency from sleep diary

    Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.

  • Depressive symptoms

    Baseline, at the end of the 2-week post-treatment and 6-month follow-up.

  • +5 more secondary outcomes

Other Outcomes (1)

  • Cognitive performance

    Baseline and at the end of the 2-week post-treatment.

Study Arms (3)

Cognitive Behavioral Treatment for Insomnia (CBT-I)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)

Lemborexant medication

EXPERIMENTAL

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: Lemborexant

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Cognitive Behavioral Treatment for Insomnia (CBT-I)BEHAVIORAL

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.

Cognitive Behavioral Treatment for Insomnia (CBT-I)
LemborexantDRUG

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.

Lemborexant medication
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Laval Centre d'étude des troubles du sommeil

Québec, Quebec, G1V 0A6, Canada

RECRUITING

Related Publications (1)

  • Chen SJ, Ivers H, Dang-Vu TT, Shapiro CM, Carney CE, Robillard R, Morin CM. Efficacy of cognitive behavioral therapy for insomnia and lemborexant medication for different subtypes of chronic insomnia: study protocol for a randomized controlled trial. BMC Psychiatry. 2025 May 9;25(1):470. doi: 10.1186/s12888-025-06878-1.

    PMID: 40346496DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Charles M Morin, PhD

    Université Laval Centre d'étude des troubles du sommeil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Lamy

CONTACT

418-656-2131manon.lamy@psy.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants assigned to the medication groups (active and placebo) and their prescribing physicians will be blind to medication treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)