Delta Waves and Cognitive Recovery (RECOPS)
Primary Purpose
Sleep Deprivation, Cognitive Impairment
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep deprivatin
Sleep recovery
Sponsored by
About this trial
This is an interventional screening trial for Sleep Deprivation focused on measuring recovery, sleep
Eligibility Criteria
Inclusion Criteria Healthy volunteer man or woman Between 18 and 45 years of age Having given written consent after having been informed of the terms of the study and the objectives of the genetic analysis performed Exclusion Criteria: Current medical treatment Chronic medical pathology, (psychol, cardiovascular or respiratory, sleep disorders) Pregnancy Sleep disorder Extreme chronotype Excessive daytime sleepiness Suspicion of anxiety or depressive disorder Estimated caffeine consumption > 200mg/d Not covered by a health insurance
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep
Arm Description
Sleep deprivation
Outcomes
Primary Outcome Measures
Delta power
EEG Delta power in Hz
Secondary Outcome Measures
Cognitive performance
Performance during PVT Test, in ms
Full Information
NCT ID
NCT05924737
First Posted
June 12, 2023
Last Updated
June 20, 2023
Sponsor
Institut de Recherche Biomedicale des Armees
Collaborators
Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
1. Study Identification
Unique Protocol Identification Number
NCT05924737
Brief Title
Delta Waves and Cognitive Recovery
Acronym
RECOPS
Official Title
Delta Waves and Cognitive Recovery During a Restricted Sleep Opportunity After Total Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche Biomedicale des Armees
Collaborators
Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a laboratory protocol in healthy adults, exposed to a prolonged period of wakefulness with a restricted opportunity for sleep (40h of wakefulness / 3h of sleep / 21h of wakefulness), we hypothesize that the relative increase in spectral power of Delta waves [ 1 - 4 Hz] in NREM in the frontal territory, identified as a potential marker of the restorative function of sleep, during a night of sleep with limited recovery (3 h of time in bed) after sleep deprivation (40 h of continuous wakefulness), will be less important in subjects with poor recovery in terms of cognitive performance than in those with good recovery.
Detailed Description
Exposure to sleep debt is one of the many stresses to which military personnel are exposed, during operational deployments or high-intensity training1.
The kinetics of cognitive performance degradation during acute sleep restriction or deprivation are relatively well studied in the literature2, with significant inter-individual variability. Restoring these cognitive functions requires sufficient sleep, sometimes for several days. However, the military work environment often offers only limited opportunities for recovery, which does not allow for ad integrum restoration of cognitive capacities, although some subjects recover better than others.
This is problematic in an environment where individual and collective performance levels are a prerequisite for safety and mission success3.
In this context, early identification of poor recuperators, who do not sufficiently restore their cognitive performance after periods of rest, would enable us to adapt more effectively the use of different countermeasures (sleep extension, naps, adapted use of caffeine...)4. This implies the availability of validated objective markers, as subjective assessments are often inadequate in this context. The temporal data classically derived from the analysis of sleep macrostructure (total sleep time, duration of wakefulness after falling asleep, time spent in the various sleep stages, etc.) are compromised when the opportunity for sleep is restricted. It therefore becomes pertinent to look for non-temporal markers that would testify to the efficiency of sleep's recuperative function.
Delta slow waves [1 - 4 Hz], which are mainly observed during deep slow-wave sleep on a sleep EEG, appear to be one of the indicators of the restorative function of sleep. They have been identified as a marker of sleep pressure5. The spectral power in this frequency range (delta power or slow-waves activity), obtained after fast Fourier transformation, bears witness to the activity of these waves. It is known to increase at the start of the night, particularly after sleep debt, and then gradually decrease, reflecting the dissipation of sleep pressure. It is recognized that high spectral power in this frequency range, particularly in deep slow wave sleep, is a marker of the "depth" of sleep6 . This depth could guarantee the restorative function of sleep. [...]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Cognitive Impairment
Keywords
recovery, sleep
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sleep deprivation followed by a short and a long recovery nigjht
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep
Arm Type
Experimental
Arm Description
Sleep deprivation
Intervention Type
Other
Intervention Name(s)
Sleep deprivatin
Intervention Description
40 hours of continuous awakening
Intervention Type
Other
Intervention Name(s)
Sleep recovery
Intervention Description
sleep recovery after 40 hours of continuous awakening
Primary Outcome Measure Information:
Title
Delta power
Description
EEG Delta power in Hz
Time Frame
One night
Secondary Outcome Measure Information:
Title
Cognitive performance
Description
Performance during PVT Test, in ms
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Healthy volunteer man or woman Between 18 and 45 years of age Having given written consent after having been informed of the terms of the study and the objectives of the genetic analysis performed
Exclusion Criteria:
Current medical treatment Chronic medical pathology, (psychol, cardiovascular or respiratory, sleep disorders) Pregnancy Sleep disorder Extreme chronotype Excessive daytime sleepiness Suspicion of anxiety or depressive disorder Estimated caffeine consumption > 200mg/d Not covered by a health insurance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien SAUVET, MD
Phone
+33662209331
Email
fabien.sauvet@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
vincent Beauchamps, MD
Email
vincent.beauchamps@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Delta Waves and Cognitive Recovery
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