Healthy
Conditions
Keywords
Sleep, Auditory stimulations, Slow oscillations
Brief summary
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
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.
Interventions
DEVICEStimulation of up-phase of sleep slow oscillation
DEVICERandom stimulation of up phase of sleep slow oscillation
DEVICENo stimulation
Sponsors
University of Paris 5 - Rene Descartes
Dreem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the amplitude of sleep slow oscillations | 3 days | Amplitude of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the number of sleep slow oscillations | 3 days | Number of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal. |
| Variation of N3 sleep stage duration | 3 days | N3 sleep duration assessed throughout 3 separate nights. The analysis is based on double scoring of polysomnography signal. |
| Variation of the number of remembered words in declarative memory tasks (word pair task) | 3 days | Number of remembered words assessed 3 separate days (30 min after awakening). |
| Variation of mood assessment measured with the profile of mood scale (POMS) | 3 days | Mood assessed 3 separate days (30 min after awakening). |
| Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS) | 3 days | Subjective sleepiness assessed 3 separate days (30 min after awakening). |
| Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT) | 3 days | Psychomotor vigilance assessed 3 separate days (30 min after awakening). |
| Variation of salivary cortisol concentration | 3 days | Salivary cortisol concentration assessed 3 separate days (5 min after awakening). |
| Variation of salivary testosterone concentration | 3 days | Salivary testosterone concentration assessed 3 separate days (5 min after awakening). |
| Variation of mental rotation capacity (mental rotatory task) | 3 days | Mental rotation capacity assessed 3 separate days (30 min after awakening). |
Countries
France
Outcome results
None listed