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CompletedNCT05924737RECOPSUpdated Jun 24, 2024

Delta Waves and Cognitive Recovery

An interventional study of Sleep deprivatin and Sleep recovery in Sleep Deprivation and Cognitive Impairment, sponsored by Institut de Recherche Biomedicale des Armees. Completed at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Institut de Recherche Biomedicale des Armees · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Sleep Deprivation
  • Cognitive Impairment

Keywords

  • recovery
  • sleep
03

In context

Sleep Deprivation

308 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.

This study's enrollment of 45 is close to the median of 44 across 253 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

Institut de Recherche Biomedicale des Armees is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Sleep

    Sleep deprivation

    Other: Sleep deprivatin · Other: Sleep recovery

Interventions

  • OtherSleep deprivatin

    40 hours of continuous awakening

  • OtherSleep recovery

    sleep recovery after 40 hours of continuous awakening

06

What researchers measure

Primary outcomes

  1. Delta power

    EEG Delta power in Hz

    Time frame: One night

Secondary outcomes

  1. Cognitive performance

    Performance during PVT Test, in ms

    Time frame: 2 days

07

Study locations

1 site
  • Institut de recherche biomédical des armées
    Brétigny-sur-Orge, 91220, France
08

References and documents

Publications

  • Schlitter Q, Beauchamps V, Quiquempoix M, Fabries P, Vacher A, Trousselard M, Dondaine T, Sauvet F. Short sleep recovery partially restores decision-making alterations induced by total sleep deprivation. Sleep Adv. 2026 Mar 26;7(2):zpag038. doi: 10.1093/sleepadvances/zpag038. eCollection 2026. PubMed 42040193 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05924737
Lead sponsor
Institut de Recherche Biomedicale des Armees
Collaborators
Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
Responsible party
Sponsor
First posted
Jun 29, 2023
Start date
Oct 1, 2023
Primary completion
Mar 30, 2024
Completion
Apr 30, 2024
Last update
Jun 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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