Trial · NCT06779149
Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
NCT06779149, Not applicable, Recruiting, Laval University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia. Trials, record NCT06779149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06779149
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
- NCT number
- NCT06779149
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Laval University
- Conditions
- Insomnia Disorder
- Interventions
- Cognitive Behavioral Treatment for Insomnia (CBT-I), Lemborexant, Placebo
- First posted
- 2025-01-16
- Last updated
- 2025-04-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia Symptom Severity | Baseline, during treatment period (weeks 0-8), at the end of the 2-week post-treatment and 6-month follow-up. | 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. |
| Secondary | 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. | Mean sleep onset latency per night in minutes from sleep diary. |
| Secondary | 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. | Mean wake after sleep onset per night in minutes from sleep diary. |
| Secondary | 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. | Mean total sleep time per night in minutes from sleep diary. |
| Secondary | 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. | Mean sleep efficiency per night in percentage from sleep diary. |
| Secondary | Depressive symptoms | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | The presence of symptoms of depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with scores of 15 and higher suggesting the need for treatment. |
| Secondary | Anxiety symptoms | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Anxiety symptom severity will be measured by the Generalised Anxiety Disorder 7-item (GAD-7). Scores range from 0 to 21, with scores of 15 and over suggesting severe anxiety. |
| Secondary | Mental well-being | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Mental well-being will be measured by the 5-item World Health Organisation Well-Being Index (WHO-5). Scores range from 0 to 100, with higher scores indicating higher well-being. |
| Secondary | Fatigue | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Fatigue severity will be measured by the 9-item Fatigue Severity Scale (FSS). Scores range from 9 to 63 . higher score indicates more severe fatigue and impairment. |
| Secondary | Functional impact of insomnia | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Work and Social Adjustment Scale (WSAS) of 5 items will be used to measure how much sleep issues impair ability to function in terms of work, home management, leisure, and relationships. Scores range from 0 to 40. Higher scores indicate more work and social impairment. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40346496 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06779149
GET https://conductscience.org/api/trials/v1/NCT06779149/registered