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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956161
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Dreem

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE September 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • Variation of salivary cortisol concentration [ Time Frame: 3 days ]
    Salivary cortisol concentration assessed 3 separate days (5 min after awakening).
  • Variation of salivary testosterone concentration [ Time Frame: 3 days ]
    Salivary testosterone concentration assessed 3 separate days (5 min after awakening).
  • Variation of mental rotation capacity (mental rotatory task) [ Time Frame: 3 days ]
    Mental rotation capacity assessed 3 separate days (30 min after awakening).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
Official Title  ICMJE Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Device: Stimulation of up-phase of sleep slow oscillation
  • Device: Random stimulation of up phase of sleep slow oscillation
  • Device: No stimulation
Study Arms  ICMJE
  • Experimental: Up phase stimulation
    Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.
    Intervention: Device: Stimulation of up-phase of sleep slow oscillation
  • Experimental: Random phase stimulation
    Auditory stimulations are randomly delivered during N3 sleep stage.
    Intervention: Device: Random stimulation of up phase of sleep slow oscillation
  • Sham Comparator: No stimulation
    The device is worn without any auditory stimulations delivered.
    Intervention: Device: No stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956161
Other Study ID Numbers  ICMJE STIMENPHASE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dreem
Study Sponsor  ICMJE Dreem
Collaborators  ICMJE University of Paris 5 - Rene Descartes
Investigators  ICMJE
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
PRS Account Dreem
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP