Delta Waves and Cognitive Recovery

NCT ID: NCT05924737

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 sleep" . This depth could guarantee the restorative function of sleep. \[...\]

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Deprivation Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sleep deprivation followed by a short and a long recovery nigjht
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep

Sleep deprivation

Group Type EXPERIMENTAL

Sleep deprivatin

Intervention Type OTHER

40 hours of continuous awakening

Sleep recovery

Intervention Type OTHER

sleep recovery after 40 hours of continuous awakening

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep deprivatin

40 hours of continuous awakening

Intervention Type OTHER

Sleep recovery

sleep recovery after 40 hours of continuous awakening

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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/day
* Not covered by a health insurance
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hotel Dieu de France Hospital

OTHER

Sponsor Role collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role collaborator

Institut de Recherche Biomedicale des Armees

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut de recherche biomédical des armées

Brétigny-sur-Orge, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-A01221-44

Identifier Type: OTHER

Identifier Source: secondary_id

2023_RECOPS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Functional Imagery of Sleepwalking
NCT02844231 COMPLETED NA