Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
- Conditions
- Healthy
- 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
- 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
Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris🇫🇷Paris, France