Trial · NCT07596342
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Deep slow-wave sleep | During the night between the day of enrollment (Day0) and the next day (Day 1). | The primary endpoint is the duration (in minutes) of deep slow-wave sleep (N3 stage) based on polysomnographic recordings. |
| Secondary | Sleep onset latency | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Total sleep time | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Duration of N1 stage | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Percentage of N1 stage | During the night between the day of enrollment (Day0) and the next day (Day 1) | |
| Secondary | Duration of N2 stage | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Percentage of N2 stage | During the night between the day of enrollment (Day0) and the next day (Day 1) | |
| Secondary | Percentage of N3 stage | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Duration of Rapid Eye Movement sleep | During the night between the day of enrollment (Day0) and the next day (Day 1). | |
| Secondary | Percentage of Rapid Eye Movement sleep | During the night between the day of enrollment (Day0) and the next day (Day 1) | |
| Secondary | Number of intra-sleep wakefulness. | During the night between the day of enrollment (Day0) and the next day (Day 1). | Intra-sleep wakefulness is defined as a period of wakefulness between sleep phases. The quantification of intra-sleep wakefulness corresponds to the number of awakenings during the night. |
| Secondary | Duration of atypical sleep. | During the night between the day of enrollment (Day0) and the next day (Day 1). | Duration of atypical sleep relative to the total sleep time. Atypical sleep is defined as slow-wave sleep equivalent to N2 stage but without sleep spindles or K-complexes |
| Secondary | Percentage of atypical sleep | During the night between the day of enrollment (Day0) and the next day (Day 1) | Percentage of atypical sleep relative to the total sleep time. Atypical sleep is defined as slow-wave sleep equivalent to N2 stage but without sleep spindles or K-complexes |
| Secondary | Duration of pathological wakefulness | During the night between the day of enrollment (Day0) and the next day (Day 1). | Duration of pathological wakefulness relative to the total sleep time is defined as rapid eye movements and chin EMG activity associated with slow delta wave EEG activity |
| Secondary | Percentage of pathological wakefulness | During the night between the day of enrollment (Day0) and the next day (Day 1) | Percentage of pathological wakefulness relative to the total sleep time is defined as rapid eye movements and chin EMG activity associated with slow delta wave EEG activity |
| Secondary | Number of micro-awakenings. | During the night between the day of enrollment (Day0) and the next day (Day 1). | Micro-awakenings are defined as an abrupt change in EEG frequency (fromdelta-theta to theta-alpha) lasting 3 to 15 seconds in a patient who has been asleep for more than 10 seconds, with or without an increase in chin EMG activity during slow-wave sleep and with an activation lasting more than one second during REM sleep. |
| Secondary | Sleep efficiency | During the night between the day of enrollment (Day0) and the next day (Day 1). | is defined as total sleep time relative to the sleep period (corresponding to total sleep time + intra-sleep wakefulness). |
| Secondary | Self-assessment questionnaire of the quality of sleep | On the day after enrollment ( Day 1) | Questionnaire of the quality of sleep :Richard-Campbell Sleep Questionnaire. min : 0 max : 100 Higher is a better outcome |
| Secondary | Hetero-evaluation questionnaire of the quality of sleep | On the day after enrollment ( Day 1) | min : 0 max : 4 Higher is a worse outcome |
| Secondary | Daytime vigilance score | On the day after enrollment ( Day 1) | Karolinska Sleepiness scale min : 1 max : 9 Higher is a worse outcome |
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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