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| Name | Class |
|---|---|
| University of Paris 5 - Rene Descartes | OTHER |
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This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.
Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality.
The subjects realize 3 conditions :
The subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Up phase stimulation | Experimental | Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. |
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| Random phase stimulation | Experimental | Auditory stimulations are randomly delivered during N3 sleep stage. |
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| No stimulation | Sham Comparator | The device is worn without any auditory stimulations delivered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation of up-phase of sleep slow oscillation | Device |
| ||
| Random stimulation of up phase of sleep slow oscillation |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the amplitude of sleep slow oscillations | Amplitude of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the number of sleep slow oscillations | Number of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal. | 3 days |
| Variation of N3 sleep stage duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien Léger, MD, PhD | EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris | Principal Investigator |
| Mounir Chennaoui, PhD | EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris | Paris | 75004 | France |
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| Device |
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| No stimulation | Device |
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N3 sleep duration assessed throughout 3 separate nights. The analysis is based on double scoring of polysomnography signal.
| 3 days |
| Variation of the number of remembered words in declarative memory tasks (word pair task) | Number of remembered words assessed 3 separate days (30 min after awakening). | 3 days |
| Variation of mood assessment measured with the profile of mood scale (POMS) | Mood assessed 3 separate days (30 min after awakening). | 3 days |
| Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS) | Subjective sleepiness assessed 3 separate days (30 min after awakening). | 3 days |
| Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT) | Psychomotor vigilance assessed 3 separate days (30 min after awakening). | 3 days |
| Variation of salivary cortisol concentration | Salivary cortisol concentration assessed 3 separate days (5 min after awakening). | 3 days |
| Variation of salivary testosterone concentration | Salivary testosterone concentration assessed 3 separate days (5 min after awakening). | 3 days |
| Variation of mental rotation capacity (mental rotatory task) | Mental rotation capacity assessed 3 separate days (30 min after awakening). | 3 days |