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Completed

NCT Number: NCT02956161

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75004, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulation of up-phase of sleep slow oscillation

Device

Random stimulation of up phase of sleep slow oscillation

Device

No stimulation

Device

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Dreem

Industry

Collaborators

  • University of Paris 5 - Rene Descartes

Registry information

Official study title

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

Acronym: STIMENPHASE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2016
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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