Trial · NCT03375203
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Baseline and Night 1 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Baseline and over first 6 hours on Night 1 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Change From Baseline in LPS as Measured by PSG on Night 13 | Baseline and Night 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | Baseline and over first 6 hours on Night 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Baseline, Over 6 hours on Nights 1 and 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Baseline, Over 8 hours on Nights 1 and 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Baseline, Nights 1 and 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Percentage of efficient sleep | MEAN |
| SECONDARY | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | Baseline, Days 1 and 13 (Hours 1 to 8) | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Baseline, Over 6 hours on Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | awakenings | MEAN |
| SECONDARY | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Baseline, Day 1 and 13 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Number of awakenings per hour | MEAN |
| SECONDARY | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minute | MEAN |
| SECONDARY | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | sleep cycles | MEAN |
| SECONDARY | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | Baseline, Days 2 and 14 | FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | Baseline, Days 2 and 14 | Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. | Units on a Scale | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03375203/outcomes