NCT05924737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 12, 2023

Last Update Submit

June 19, 2024

Conditions

Keywords

recoverysleep

Outcome Measures

Primary Outcomes (1)

  • Delta power

    EEG Delta power in Hz

    One night

Secondary Outcomes (1)

  • Cognitive performance

    2 days

Study Arms (1)

Sleep

EXPERIMENTAL

Sleep deprivation

Other: Sleep deprivatinOther: Sleep recovery

Interventions

40 hours of continuous awakening

Sleep

sleep recovery after 40 hours of continuous awakening

Sleep

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de recherche biomédical des armées

Brétigny-sur-Orge, 91220, France

Location

MeSH Terms

Conditions

Sleep DeprivationCognitive Dysfunction

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCognition DisordersNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Sleep deprivation followed by a short and a long recovery nigjht
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 29, 2023

Study Start

October 1, 2023

Primary Completion

March 30, 2024

Study Completion

April 30, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations