Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04761796 |
| Other study ID # |
2020-A02069-30 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2021 |
| Est. completion date |
May 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Direction Centrale du Service de Santé des Armées |
| Contact |
Nicolas Huiban, MD |
| Phone |
04 83 16 22 65 |
| Email |
nicolas.huiban[@]intradef.gouv.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Sleep is a physiological function that plays an essential role in many somatic, cognitive or
psychological processes. Although the criteria for sleep effectiveness are multiple, its
quantity is unanimously recognized as a major determinant of health. Too little sleep time is
indeed associated with an increase in metabolic, cardiovascular and accidental morbidity and
mortality, caused by sleepiness during journeys or at the workplace. In the wake of recent
work in the general French population, a specific study on the prevalence and factors
associated with sleeping time and chronic insomnia among flight members appears relevant.
Chronic insomnia and sleep debt can thus be assumed to be more common among aircrews than in
the general population, due to these specific operational constraints. Better consideration
of certain sleep disorders in professional flight members could make it possible to adapt
prevention or countermeasures strategies intended to optimize risk management with regard to
flight safety.
Description:
Today, time dedicated to sleep is in competition with working time, transport time or time
spent on new technologies, in a professional or recreational setting. Faced with the public
health issue thus raised, studies have highlighted the interest of studying the relationships
between sleep time and socio-demographic factors, beyond the mere implication of sleep
pathologies. However, among these pathologies, the place of insomnia is not negligible: it is
indeed the most frequent sleep disorder (16% of French people in 2010) and represents an
important source of involuntary reduction in sleep time, likely to increase inappropriate
sleepiness during periods of wakefulness, in the context of activities sometimes involving
safety.
Flight crews are exposed to specific operational constraints, both in civilian and military
environments, likely to compromise the recovery function of sleep (operational fatigue,
extended working ranges, repetitions of time differences, etc.). These constraints, conducive
to compromising the levels of vigilance and cognitive performance required, are also at risk
of cardio-metabolic complications. They therefore raise the issue of controlling risks and
maintaining aviation safety.
The issue of pilot fatigue remains an essential issue for the safety of flight operations. In
the context of air transport, several determinants of operational fatigue have been
identified, such as irregular sleep schedules, large, irregular and sometimes unpredictable
activity ranges, sleep debts, night flights and circadian disturbances in connection with
multiple and repeated changes of time zones. If these factors must deal within airlines with
rules more often based on alternating "work / rest" than "sleep / wakefulness", the laws and
regulations in force, within the aeronautical industry, are now oriented towards scientific
approaches to the management of fatigue in commercial aviation, by emphasizing the importance
of sleep and taking into account circadian rhythms.
Currently, the vast majority of studies devoted to the sleep of aviation flight personnel are
therefore limited to the cases of commercial aviation airline pilots. They have established
that most flights, especially over long-haul sectors, involve disturbances of the circadian
rhythm, fractionation and restriction of sleep that are harmful to cognitive performance and
the risk of accidents. Most publications have looked for associations between sleep measures
and performance in an operational context. Some have been able to demonstrate that the
classic methods of evaluating sleep in flight (by actimetric readings, sleep diaries or
subjective evaluation of self-questionnaires) were correlated with reference data obtained by
polysomnography, strongly for the duration of sleep but moderately to weakly for its
effectiveness. In the specific case of sleep duration, self-report questionnaires have proven
to be a reliable alternative to in-flight actimetric measurements.
The majority of studies have been designed considering pilot sleep as a determinant of
in-flight performance, especially during long (12 to 16 hours) and very long (over 16 hours)
flights. On the other hand, taking into account the consequences of aeronautical activity on
the sleep of pilots is relatively rare in the scientific literature. Thus, most "ecological"
studies, known as field studies, generally focus on specific flights with limited time slots
and small sample sizes, limiting the scope of the results regarding the effects of flights on
sleep. Currently, the main topic of interest is still the sleep of pilots immediately before,
during and after duty periods, but without characterizing their baseline sleep, observed
during periods of rest.
From this perspective, a study looked at the basic sleep of airline pilots, making
comparisons to samples of the general North American population. On a total number of 332
long-haul pilots, the actimetric data revealed longer sleep times during rest periods,
highlighting the influence of environmental stresses deemed to be risky to health. In
addition, the influence of socio-demographic and professional parameters was reported in a
study of 435 pilots. The high prevalence of sleep disorders, drowsiness and fatigue have been
documented, as well as an increased risk of fatigue for flight crews on short and medium-haul
flights, in connection with the working hours and repetition of rotations.
This study project therefore fits into this global context, in the light of 3 innovative
perspectives:
- Target a rich and varied professional panel of aeronautical specialties (not limited to
airline pilots only), integrating civil and military status, engaged in distinct
operational frameworks but where risk control and aviation safety prevail;
- Recruit a large sample, without current equivalent to our knowledge in the scientific
literature;
- Benefit from equivalent and recent data from a study carried out on a very large
representative sample of the general French population
Other known NCT identifiers
