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

Healthy Clinical Trial

— STIMENPHASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956161
• Other study ID #: STIMENPHASE
• Status: Completed
• Phase: N/A
• First received: October 20, 2016
• Last updated: November 2, 2016
• Start date: September 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Rythm
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Stimulation of up-phase of sleep slow oscillation

• Random stimulation of up phase of sleep slow oscillation

• No stimulation

Locations

Country	Name	City	State
France	Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Rythm	University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Variation of the number of sleep slow oscillations	Number of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.	3 days	No
Secondary	Variation of N3 sleep stage duration	N3 sleep duration assessed throughout 3 separate nights. The analysis is based on double scoring of polysomnography signal.	3 days	No
Secondary	Variation of the number of remembered words in declarative memory tasks (word pair task)	Number of remembered words assessed 3 separate days (30 min after awakening).	3 days	No
Secondary	Variation of mood assessment measured with the profile of mood scale (POMS)	Mood assessed 3 separate days (30 min after awakening).	3 days	No
Secondary	Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)	Subjective sleepiness assessed 3 separate days (30 min after awakening).	3 days	No
Secondary	Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)	Psychomotor vigilance assessed 3 separate days (30 min after awakening).	3 days	No
Secondary	Variation of salivary cortisol concentration	Salivary cortisol concentration assessed 3 separate days (5 min after awakening).	3 days	No
Secondary	Variation of salivary testosterone concentration	Salivary testosterone concentration assessed 3 separate days (5 min after awakening).	3 days	No
Secondary	Variation of mental rotation capacity (mental rotatory task)	Mental rotation capacity assessed 3 separate days (30 min after awakening).	3 days	No