Clinical trial NCT02956161: Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
Official title: Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Sleep
Auditory stimulations
Slow oscillations
Lead sponsor: Dreem
Sponsor class: INDUSTRY
Collaborators: name: University of Paris 5 - Rene Descartes
First posted: 2016-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of the amplitude of sleep slow oscillations
timeFrame: 3 days
Secondary outcomes:
measure: Variation of the number of sleep slow oscillations
timeFrame: 3 days
measure: Variation of N3 sleep stage duration
timeFrame: 3 days
measure: Variation of the number of remembered words in declarative memory tasks (word pair task)
timeFrame: 3 days
measure: Variation of mood assessment measured with the profile of mood scale (POMS)
timeFrame: 3 days
measure: Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)
timeFrame: 3 days
measure: Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)
timeFrame: 3 days
measure: Variation of salivary cortisol concentration
timeFrame: 3 days
measure: Variation of salivary testosterone concentration
timeFrame: 3 days
measure: Variation of mental rotation capacity (mental rotatory task)
timeFrame: 3 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris
Study officials:
affiliation: EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris
name: Damien Léger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris
name: Mounir Chennaoui, PhD
role: STUDY_DIRECTOR
References: