- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924737
Delta Waves and Cognitive Recovery (RECOPS)
Delta Waves and Cognitive Recovery During a Restricted Sleep Opportunity After Total Sleep
Study Overview
Status
Conditions
Intervention / Treatment
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. [...]
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabien SAUVET, MD
- Phone Number: +33662209331
- Email: fabien.sauvet@gmail.com
Study Contact Backup
- Name: vincent Beauchamps, MD
- Email: vincent.beauchamps@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep
Sleep deprivation
|
40 hours of continuous awakening
sleep recovery after 40 hours of continuous awakening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta power
Time Frame: One night
|
EEG Delta power in Hz
|
One night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance
Time Frame: 2 days
|
Performance during PVT Test, in ms
|
2 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023_RECOPS
- 2023-A01221-44 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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