Trial · NCT03375203
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Baseline and Night 1 | Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement. |
| 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 | PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement. |
| Secondary | Change From Baseline in LPS as Measured by PSG on Night 13 | Baseline and Night 13 | LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement. |
| 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 | PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement. |
| 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 | TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. |
| 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 | TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. |
| Secondary | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Baseline, Nights 1 and 13 | Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement. |
| 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) | Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement. |
| 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 | PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement. |
| Secondary | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement. |
| Secondary | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement. |
| Secondary | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement. |
| Secondary | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement. |
| Secondary | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure REM duration (time to first REM period from sleep onset). |
| Secondary | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep. |
| Secondary | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 and 13 | PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured. |
| Secondary | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the number of sleep cycles. |
| Secondary | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement. |
| 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 | CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement. |
| 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 | The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. |
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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