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

NCT ID: NCT02956161

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Sleep Auditory stimulations Slow oscillations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Up phase stimulation

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

Group Type EXPERIMENTAL

Stimulation of up-phase of sleep slow oscillation

Intervention Type DEVICE

Random phase stimulation

Auditory stimulations are randomly delivered during N3 sleep stage.

Group Type EXPERIMENTAL

Random stimulation of up phase of sleep slow oscillation

Intervention Type DEVICE

No stimulation

The device is worn without any auditory stimulations delivered.

Group Type SHAM_COMPARATOR

No stimulation

Intervention Type DEVICE

Interventions

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Stimulation of up-phase of sleep slow oscillation

Intervention Type DEVICE

Random stimulation of up phase of sleep slow oscillation

Intervention Type DEVICE

No stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Paris 5 - Rene Descartes

OTHER

Sponsor Role collaborator

Dreem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damien Léger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris

Mounir Chennaoui, PhD

Role: STUDY_DIRECTOR

EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris

Locations

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Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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STIMENPHASE

Identifier Type: -

Identifier Source: org_study_id