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Sleep DeprivationRECOPSNCT05924737

Delta Waves and Cognitive Recovery

A study testing Sleep deprivatin and Sleep recovery in people with Sleep Deprivation and Cognitive Impairment, run by Institut de Recherche Biomedicale des Armees at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Deprivation, Cognitive Impairment
What is being tested?
Sleep deprivatin and Sleep recovery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
1 Oct 2023to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Current medical treatment
  • Chronic medical pathology, (psychol, cardiovascular or respiratory, sleep disorders)
  • Pregnancy
  • Sleep disorder
  • Extreme chronotype
  • Excessive daytime sleepiness
Show all 9Show fewer
  • Suspicion of anxiety or depressive disorder
  • Estimated caffeine consumption > 200mg/day
  • Not covered by a health insurance

Trial locations and contacts

1 site in 1 country.

France1 site
  • Institut de recherche biomédical des armées

    Brétigny-sur-Orge, 91220

Other trials in France

About this study

Official title: Delta Waves and Cognitive Recovery During a Restricted Sleep Opportunity After Total 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.

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.

Being tested
Sleep deprivatin, Sleep recovery
Keywords
recovery, sleep
Medical subject headings
Sleep Deprivation, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep deprivatinOther

    40 hours of continuous awakening

  • Sleep recoveryOther

    sleep recovery after 40 hours of continuous awakening

Study groups in NCT05924737
Study groupRoleWhat they receive
SleepExperimentalSleep deprivation
Receives: Other: Sleep deprivatin; Other: Sleep recovery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delta power

    EEG Delta power in Hz

    Measured: One night

Secondary outcomes (1)
  1. Cognitive performance

    Performance during PVT Test, in ms

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Mar 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Sleep deprivation followed by a short and a long recovery nigjht
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924737
Sponsor's protocol ID
2023_RECOPS
Other IDs
2023-A01221-44
Acronym
RECOPS
Status last verified
Jun 2024
First submitted
12 Jun 2023
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Sleep deprivatin and Sleep recovery in people with Sleep Deprivation and Cognitive Impairment, run by Institut de Recherche Biomedicale des Armees at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta power (time frame: One night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924737, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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