Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. Random condition : Auditory stimulations are randomly delivered during N3 sleep stage. Placebo condition: The device is worn without any auditory stimulations delivered. 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.

Official Title
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Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep

Conditions
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Healthy

Intervention / Treatment
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* Device: Stimulation of up-phase of sleep slow oscillation
* Device: Random stimulation of up phase of sleep slow oscillation
* Device: No stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subject moderate morningness, intermediate or moderate eveningness chronotype (Horne & Östberg questionnaire) Exclusion Criteria: sleep disorder according to the ICSD-3 or DSM-5 travelling away from more than a time zone in the previous month acute or chronic disorders (cardio-vascular, respiratory, neurologic, psychiatric) night shifts work smoking more than 5 cigarettes per day drinking more than 5 glass of alcohol per week consuming excessive drinks with xanthics (coffee, tea, coke more than 6 cups per day). having a body mass index >30kg.m -2 being pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Up phase stimulation<br>Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. | Device: Stimulation of up-phase of sleep slow oscillation<br> <br> |
| Experimental: Random phase stimulation<br>Auditory stimulations are randomly delivered during N3 sleep stage. | Device: Random stimulation of up phase of sleep slow oscillation<br> <br> |
| Sham Comparator: No stimulation<br>The device is worn without any auditory stimulations delivered. | Device: No stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Auditory stimulations, Slow oscillations