RECOPS: Delta Waves and Cognitive Recovery

Sponsor
Institut de Recherche Biomedicale des Armees (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924737
Collaborator
Hotel Dieu de France Hospital (Other), University of Paris 5 - Rene Descartes (Other)
45
1
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sleep deprivatin
  • Other: Sleep recovery
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Sleep deprivation followed by a short and a long recovery nigjhtSleep deprivation followed by a short and a long recovery nigjht
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Delta Waves and Cognitive Recovery During a Restricted Sleep Opportunity After Total Sleep
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep

Sleep deprivation

Other: Sleep deprivatin
40 hours of continuous awakening

Other: Sleep recovery
sleep recovery after 40 hours of continuous awakening

Outcome Measures

Primary Outcome Measures

  1. Delta power [One night]

    EEG Delta power in Hz

Secondary Outcome Measures

  1. Cognitive performance [2 days]

    Performance during PVT Test, in ms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut de Recherche Biomedicale des Armees
  • Hotel Dieu de France Hospital
  • University of Paris 5 - Rene Descartes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Recherche Biomedicale des Armees
ClinicalTrials.gov Identifier:
NCT05924737
Other Study ID Numbers:
  • 2023_RECOPS
  • 2023-A01221-44
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut de Recherche Biomedicale des Armees
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2023