NCT02956161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

October 20, 2016

Last Update Submit

November 2, 2016

Conditions

Healthy

Keywords

SleepAuditory stimulationsSlow oscillations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Variation of the number of sleep slow oscillations

    3 days

  • Variation of N3 sleep stage duration

    3 days

  • 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 subjective sleepiness measured with the Karolinska sleepiness scale (KSS)

    3 days

  • +4 more secondary outcomes

Study Arms (3)

Up phase stimulation

EXPERIMENTAL

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

Random phase stimulation

EXPERIMENTAL

Auditory stimulations are randomly delivered during N3 sleep stage.

Device: Random stimulation of up phase of sleep slow oscillation

No stimulation

SHAM COMPARATOR

The device is worn without any auditory stimulations delivered.

Device: No stimulation

Interventions

Stimulation of up-phase of sleep slow oscillationDEVICE
Up phase stimulation
Random stimulation of up phase of sleep slow oscillationDEVICE
Random phase stimulation
No stimulationDEVICE
No stimulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subject
  • moderate morningness, intermediate or moderate eveningness chronotype (Horne \& Östberg questionnaire)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75004, France

Location

Study Officials

  • Damien Léger, MD, PhD

    EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris

    PRINCIPAL INVESTIGATOR

  • Mounir Chennaoui, PhD

    EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 7, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

FR(1)