Trial · NCT03626727
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Subjective Daytime Sleepiness | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in subjective daytime sleepiness assessed through a daily questionnaire about frequency and duration of daytime naps, frequency of sleep attacks. |
| Primary | Change in Sleep Duration | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in sleep duration assessed by actigraphy-estimated total sleep time (TST). |
| Primary | Change in Clinical Condition | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in clinical condition as assessed by Clinical Global Impression (CGI) assessment. CGI assesses a clinician's view of a patient's global functioning before and after initiating medication. It is broken up into CGI-S (Severity) and CGI-I (Improvement). CGI-S is one question assesses how clinically ill a patient is at time of assessment. it is on a 1-7 scale with 1 being normal and 7 being among the most extremely ill patients. CGI-I looks at improvement in patients functioning once medication starts. it is also on a 1-7 scale with 1 being very much improved since initiation of treatment and 7 being very much worse. |
| Primary | Change in Subjective Daytime Sleepiness (ESS) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in daytime sleepiness will be assessed through changes in Epworth Sleepiness Scale (ESS) scores. The ESS measures sleepiness of a participant. It is eight questions with a scale of 0 - 3 with 0 being no chance of dozing and 3 being high chance of dozing. The total score of eight questions is reported. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of nocturnal awakenings) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of nocturnal awakenings. |
| Secondary | Change in Nocturnal Sleep Quality (Duration of nocturnal awakenings) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on duration of nocturnal awakenings. |
| Secondary | Change in Nocturnal Sleep Quality (Subjective amount of sleep) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on subjective amount of sleep each night. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of sleep walking) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of sleep walking. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of hypnagogic hallucinations) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of hypnagogic hallucinations. |
| Secondary | Change in Nocturnal Sleep Quality (Change in Pittsburgh Sleep Quality index) scores) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by changes in Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI assesses sleep quality. It is broken down into seven components, with scales from 0 - 3 with 0 being better quality of sleep and 3 being a more poor quality of sleep. The Global PSQI score is taken from the sum of the seven component scores. |
| Secondary | Change in Nocturnal Sleep Quality (actigraphy) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality measured by actigraphy. |
| Secondary | Change in Global Functioning | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in global functioning evaluated by the Sheehan Disability Scale (SDS). The SDS assesses functional impairment in three subscales: in work/school, social, and family life. Each is subscale is 1-10 with 1 being no disability/impairment and 10 be extreme disability/impairment. These three subscales are added together to give the global functional impairment score which ranges from 0 being unimpaired to 30 being highly impaired. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03626727/registered