Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
- Conditions
- Healthy
- Interventions
- Device: No stimulationDevice: Stimulation of up-phase of sleep slow oscillationDevice: Random stimulation of up phase of sleep slow oscillation
- Registration Number
- NCT02956161
- Lead Sponsor
- Dreem
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- healthy subject
- moderate morningness, intermediate or moderate eveningness chronotype (Horne & Östberg questionnaire)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No stimulation No stimulation The device is worn without any auditory stimulations delivered. Up phase stimulation Stimulation of up-phase of sleep slow oscillation Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. Random phase stimulation Random stimulation of up phase of sleep slow oscillation Auditory stimulations are randomly delivered during N3 sleep stage.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 mental rotation capacity (mental rotatory task) 3 days Mental rotation capacity assessed 3 separate days (30 min after awakening).
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 subjective sleepiness measured with the Karolinska sleepiness scale (KSS) 3 days Subjective sleepiness assessed 3 separate days (30 min after awakening).
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 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).
Trial Locations
- Locations (1)
Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris
🇫🇷Paris, France