Trial · NCT07132086
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
NCT07132086, Completed, Azienda Ospedaliero, Universitaria Pisana
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting. Trials, record NCT07132086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07132086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
- NCT number
- NCT07132086
- Status
- Completed
- Enrollment
- 31 participants, actual
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Conditions
- Insomnia Chronic
- Interventions
- Daridorexant 50 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical setting
- First posted
- 2025-08-20
- Last updated
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in total sleep time after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) total sleep time (TST) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective TST \[minutes/night\] * Change in actigraphic TST \[minutes/night\] |
| Primary | Change in wake after sleep onset after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) wake after sleep onset (WASO) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective WASO \[minutes/night\] * Change in actigraphic WASO \[minutes/night\] |
| Primary | Change in sleep efficiency after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) sleep efficiency (SE) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective SE. Subjective SE is estimated as the ratio of subjective TST to Time in bed \[%\] * Change in actigraphic SE. Actigraphic SE is estimated as the ratio of actigraphic TST to Time in bed \[%\] |
| Primary | Change in sleep regularity index after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in objective (actigraphic) sleep regularity index (SRI) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measure: \- Change in Sleep Regularity Index (SRI) \[%\] |
| Primary | Change in self-reported sleep questionnaires after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in self-reported sleep questionnaires from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in sleep quality (PSQI score) \[range: 0-21\] * Change in insomnia severity (ISI score) \[range: 0-28\] * Change in daytime functioning and alertness (IDSIQ total score) \[range: 0-100\] |
| Secondary | Change in TST misperception after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in TST misperception from baseline to 3 months after initiating daridorexant 50 mg. TST misperception is calculated as the difference between subjective and actigraphic TST (hours) |
| Secondary | Change in SE misperception after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in SE misperception from baseline to 3 months after initiating daridorexant 50 mg. SE misperception is calculated as the difference between subjective and actigraphic SE (%) |
| Secondary | Change in WASO misperception after 3 months of daridorexant treatment | From baseline (Day 0) to 3 months after treatment initiation | This outcome assesses the change in WASO misperception from baseline to 3 months after initiating daridorexant 50 mg. WASO misperception is calculated as the difference between subjective and actigraphic WASO (minutes) |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07132086
GET https://conductscience.org/api/trials/v1/NCT07132086/registered