Trial · NCT07328594
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | QSU Brief Smoking Desire | End of day on days 3, 5, 7 of weeks 1, 2, and 3. | Assesses desire to smoke. Range 7-49. Higher score indicates higher craving to smoke. |
| Secondary | Number of cigarettes/vape products smoked | Reported daily for entire study (2 days + 3 weeks). | Daily Sleep Diary includes number of cigarettes/vape products smoked. |
| Other | Morningness/Eveningness questionnaire | 2 days before beginning study medication | Scores range from 16-83, with higher score indicating morning type and lower score evening type. |
| Other | GAD-67 Anxiety | 2 days before beginning study medication and last day of the study (3 weeks, 2 days). | Assesses anxiety levels over last 2 weeks. Range is 0-21, higher score indicating higher anxiety. |
| Other | Patient Health Questionnaire 9 (PHQ 9 Depression) | 2 days before beginning study medication and last day of the study (3 weeks, 2 days). | Assesses depression levels. Range is 1-27, higher score indicating higher depression. |
| Other | Readiness to Quit | 2 days before beginning study medication and on last day of study (3 weeks, 2 days). | Readiness to quit tobacco. Scale is 1-10, with higher score indicating more important to quit. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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