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Clinical Trials/NCT02956161
NCT02956161
Completed
Not Applicable

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

Dreem1 site in 1 country24 target enrollmentSeptember 2016
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Dreem
Enrollment
24
Locations
1
Primary Endpoint
Variation of the amplitude of sleep slow oscillations
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
November 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Dreem
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Variation of the number of remembered words in declarative memory tasks (word pair task)(3 days)
  • Variation of mood assessment measured with the profile of mood scale (POMS)(3 days)
  • Variation of mental rotation capacity (mental rotatory task)(3 days)
  • Variation of N3 sleep stage duration(3 days)
  • Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)(3 days)
  • Variation of the number of sleep slow oscillations(3 days)
  • Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)(3 days)
  • Variation of salivary cortisol concentration(3 days)
  • Variation of salivary testosterone concentration(3 days)

Study Sites (1)

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