search
Back to results

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
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Deprivation focused on measuring recovery, sleep

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    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
    search

    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

    We'll reach out to this number within 24 hrs