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

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join 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

Where this trial is running

• Université Laval Centre d'étude des troubles du sommeil, Québec, Quebec, Canada

Who to contact

Manon Lamy · 418-656-2131 · manon.lamy@psy.ulaval.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06779149.