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

Dreem

Status: Completed

Conditions: Healthy

Treatments: Device: Random stimulation of up phase of sleep slow oscillation; Device: No stimulation; Device: Stimulation of up-phase of sleep slow oscillation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02956161

STIMENPHASE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

Up phase stimulation

Experimental group

Description:

Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.

Treatment:

Device: Stimulation of up-phase of sleep slow oscillation

Random phase stimulation

Experimental group

Description:

Auditory stimulations are randomly delivered during N3 sleep stage.

Treatment:

Device: Random stimulation of up phase of sleep slow oscillation

No stimulation

Sham Comparator group

Description:

The device is worn without any auditory stimulations delivered.

Treatment:

Device: No stimulation