Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT02956161
Status:
COMPLETED
Last Update Posted:
2016-11-07
First Post:
2016-10-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
Sponsor:
Dreem
Organization:
Study Overview
Official Title:
Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STIMENPHASE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: