Trial · NCT07328594
Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
NCT07328594, Phase 4, Not yet recruiting, Legacy Health System
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking. Trials, record NCT07328594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07328594
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
- NCT number
- NCT07328594
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Legacy Health System
- Conditions
- Smoking, Nicotine, Tobacco, Addiction, Substance Use Disorders, Insomnia, Sleep
- Interventions
- Daridorexant 50 mg, Placebo
- First posted
- 2026-01-09
- Last updated
- 2026-01-09
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep Quality | 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration. | Sleep device to assess: latency to sleep, number of awakenings during the night, and sleep stages. |
| Primary | Daytime alertness | Assessed 3 times per day (morning, midday, evening), 3 times per week for 3 weeks. | Assess daytime alertness using a 5 min psychomotor vigilance task. Higher score indicates lower alertness. |
| Primary | Insomnia Severity Index | Assess at prescreening and on last day of the study (3 weeks and 2 days) | Assesses extent of insomnia. Range is 0-28. Higher score indicates high level of insomnia. |
| Primary | Sleep Quality-sleep diary | Assessed 2 days prior to taking daridorexant and daily for 3 weeks during daily daridorexant administration. | Daily sleep diary to assess self-reported sleep |
| Primary | Pittsburgh Sleep Quality Index | 2 days before beginning study medication. | Assesses sleep quality (duration, disturbance, latency) over last 1 month. Range is 0-21; higher score indicates worse sleep quality. |
| Primary | PROMIS Sleep-Short Form 8a | 2 days before beginning study medication and last day of weeks 1, 2, 3. | Assesses sleep quality over last 7 days. Range is 8-40, higher score indicates worse sleep/low alertness. |
| Primary | Karolinska Sleepiness Scale | Given 3X/day on days 3, 5, 7 of weeks 1, 2, 3. | Assesses daytime alertness - single question. Range is 1-10. Higher score indicates lower alertness. |
| Secondary | Fagerstrom | Measure at pre-screening and at the end of each week for 3 weeks. | Assesses extent of nicotine dependence. Range is 0-10. Higher score indicates higher dependence. |
| Secondary | Smoking History and Habits | Measure at pre-screening. | Must smoke 10 or more cigarettes per day. |
| Secondary | Minnesota Scale Withdrawal from Nicotine | 2 days before beginning study medication, end of day on days 3, 5, 7 of weeks 1, 2, and 3. | Assesses nicotine withdrawal symptoms over last 24 hr. Range is 0-60, higher score indicating higher withdrawal signs/symptoms. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Psychomotor Vigilance Task | Primary outcome |
Source ConductCognition
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/NCT07328594
GET https://conductscience.org/api/trials/v1/NCT07328594/registered