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

November 2, 2016 updated by: Dreem

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75004
        • Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Up phase stimulation
Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.
Device: Stimulation of up-phase of sleep slow oscillation
Experimental: Random phase stimulation
Auditory stimulations are randomly delivered during N3 sleep stage.
Device: Random stimulation of up phase of sleep slow oscillation
Sham Comparator: No stimulation
The device is worn without any auditory stimulations delivered.
Device: No stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the amplitude of sleep slow oscillations
Time Frame: 3 days
Amplitude of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the number of sleep slow oscillations
Time Frame: 3 days
Number of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.
3 days
Variation of N3 sleep stage duration
Time Frame: 3 days
N3 sleep duration assessed throughout 3 separate nights. The analysis is based on double scoring of polysomnography signal.
3 days
Variation of the number of remembered words in declarative memory tasks (word pair task)
Time Frame: 3 days
Number of remembered words assessed 3 separate days (30 min after awakening).
3 days
Variation of mood assessment measured with the profile of mood scale (POMS)
Time Frame: 3 days
Mood assessed 3 separate days (30 min after awakening).
3 days
Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)
Time Frame: 3 days
Subjective sleepiness assessed 3 separate days (30 min after awakening).
3 days
Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)
Time Frame: 3 days
Psychomotor vigilance assessed 3 separate days (30 min after awakening).
3 days
Variation of salivary cortisol concentration
Time Frame: 3 days
Salivary cortisol concentration assessed 3 separate days (5 min after awakening).
3 days
Variation of salivary testosterone concentration
Time Frame: 3 days
Salivary testosterone concentration assessed 3 separate days (5 min after awakening).
3 days
Variation of mental rotation capacity (mental rotatory task)
Time Frame: 3 days
Mental rotation capacity assessed 3 separate days (30 min after awakening).
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dreem

Collaborators

University of Paris 5 - Rene Descartes

Investigators

  • Principal Investigator: Damien Léger, MD, PhD, EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris
  • Study Director: Mounir Chennaoui, PhD, EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STIMENPHASE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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