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.
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
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.
- Conditions
- Sleep Deprivation, Cognitive Impairment
- 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 group | Role | What they receive |
|---|---|---|
| Sleep | Experimental | Sleep 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.
Delta power
EEG Delta power in Hz
Measured: One night
Secondary outcomes (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.
- First posted29 Jun 2023
- Study start1 Oct 2023
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Collaborators
- Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta Waves and Cognitive Recovery During a Restricted Sleep Opportunity After Total Sleep
- ClinicalTrials.gov ID
- NCT05924737
- Acronym / sponsor ID
- RECOPS / 2023_RECOPS
- Conditions
- Sleep Deprivation, Cognitive Impairment
- Keywords
- recovery, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Collaborators
- Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sleep deprivation followed by a short and a long recovery nigjht
| Arm | Type | Receives |
|---|---|---|
| Sleep | Experimental | Other: Sleep deprivatin, Other: Sleep recoverySleep deprivation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Current medical treatment
- Chronic medical pathology, (psychol, cardiovascular or respiratory, sleep disorders)
- Pregnancy
- Sleep disorder
- Extreme chronotype
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivatin40 hours of continuous awakening | Other | Sleep |
| Sleep recoverysleep recovery after 40 hours of continuous awakening | Other | Sleep |
Primary outcome
Delta power
Time frame: One night
EEG Delta power in Hz
1 secondary outcome
Cognitive performance
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 42040193Schlitter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.