Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05924737 |
| Other study ID # |
2023_RECOPS |
| Secondary ID |
2023-A01221-44 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Institut de Recherche Biomedicale des Armees |
| Contact |
Fabien SAUVET, MD |
| Phone |
+33662209331 |
| Email |
fabien.sauvet[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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 sleep6 . This depth could guarantee the restorative
function of sleep. [...]
