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Trial record 1 of 1 for:    NCT02956161
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Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality (STIMENPHASE)

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Device: Stimulation of up-phase of sleep slow oscillation Device: Random stimulation of up phase of sleep slow oscillation Device: No stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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. 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).

  4. 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).

  5. 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).

  6. 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).

  7. Variation of salivary cortisol concentration [ Time Frame: 3 days ]
    Salivary cortisol concentration assessed 3 separate days (5 min after awakening).

  8. Variation of salivary testosterone concentration [ Time Frame: 3 days ]
    Salivary testosterone concentration assessed 3 separate days (5 min after awakening).

  9. Variation of mental rotation capacity (mental rotatory task) [ Time Frame: 3 days ]
    Mental rotation capacity assessed 3 separate days (30 min after awakening).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956161


Locations
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France
Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris
Paris, France, 75004
Sponsors and Collaborators
Dreem
University of Paris 5 - Rene Descartes
Investigators
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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

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Responsible Party: Dreem
ClinicalTrials.gov Identifier: NCT02956161     History of Changes
Other Study ID Numbers: STIMENPHASE
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dreem:
Sleep
Auditory stimulations
Slow oscillations