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

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: Healthy
• Intervention / Treatment: Device: No stimulation; Device: Stimulation of up-phase of sleep slow oscillation; Device: Random stimulation of up phase of sleep slow oscillation

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	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	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)	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)	Mood assessed 3 separate days (30 min after awakening).	3 days
Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)	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)	Psychomotor vigilance assessed 3 separate days (30 min after awakening).	3 days
Variation of salivary cortisol concentration	Salivary cortisol concentration assessed 3 separate days (5 min after awakening).	3 days
Variation of salivary testosterone concentration	Salivary testosterone concentration assessed 3 separate days (5 min after awakening).	3 days
Variation of mental rotation capacity (mental rotatory task)	Mental rotation capacity assessed 3 separate days (30 min after awakening).	3 days

Collaborators and Investigators

• 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

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: Sleep; Slow oscillations; Auditory stimulations
• Other Study ID Numbers: STIMENPHASE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES