Trial · NCT06225947
Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia
NCT06225947, Unknown, Guangdong Provincial People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia. Trials, record NCT06225947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06225947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia
- NCT number
- NCT06225947
- Status
- Unknown
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Guangdong Provincial People's Hospital
- Conditions
- Insomnia
- Interventions
- Lemborexant 5 MG
- First posted
- 2024-01-26
- Last updated
- 2024-07-30
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with insomnia remission | Baseline, week 1, week 2, week 4, week 12 | Percentage of patients with total ISI score below 8 points after Lemborexant treatment. Insomnia remission is defined as total ISI below 8points. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Retention rate of Lemborexant treatment at each visit | up to week 12 | The retention rate is defined as the percentage of participants remaining on Lemborexant treatment regardless of treatment pattern, starting from the first dose of study drug. The retention is primarily defined as follows: * Patients who wish to continue LEM treatment at each visit. * Patients who wish to continue LEM treatment at each visit. but do not actually continue with a reason not related to the efficacy or safety of LEM treatment (including, but not limited to relocation, clinic transfer, or a burden of site visit expenses) |
| Secondary | Change from baseline of mean ISI score at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ISI score from baseline was defined as the average score of ISI scale at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Change from baseline of mean ISI score at LEM 5mg and 10 mg at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ISI score from baseline was defined as the average score of ISI scale at LEM 5mg and LEM 10mg at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ISI score from baseline was defined as the average score of ISI scale at age \<55 and ≥ 55 at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Change from baseline of mean ISI score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ISI score from baseline was defined as the average score of ISI scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline. * LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy. * Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM. * Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Change from baseline of mean ISI score in patients with depression symptoms at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ISI score from baseline was defined as the average score of ISI scale in patients with depression symptoms at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. |
| Secondary | Proportion of insomnia treatment responders at each visit | Baseline, week 4, week 12 | Responder was defined as total ISI reduction≥6 compared to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity. |
| Secondary | Changes of mean ESS score at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ESS score from baseline was defined as the average score of ESS scale at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. |
| Secondary | Changes of mean ESS score at LEM 5mg and 10mg at each visit | Baseline, week 1, week 2, week 4, week 12 | Change of mean ESS score from baseline was defined as the average score of ESS scale at LEM 5mg and 10 mg at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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 |
|---|---|
| 42226892 | 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/NCT06225947
GET https://conductscience.org/api/trials/v1/NCT06225947/registered?page=2