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Chronic InsomniaSOMNAVINCT04761796

Sleep Time and Insomnia Factors Among Professional Flight Members

An observational study of Chronic Insomnia and Sleepiness, run by Direction Centrale du Service de Santé des Armées at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Insomnia, Sleepiness
What is being tested?
Sleeping condition self-questionnaire
How many people
2,700 participants
Where
1 siteFrance
Study dates
26 Oct 2021to May 2022
Phase
Observational
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population is composed of military aircrew.

Who may be able to join

  • Between 18 and 60 years of age
  • Professional flight members
  • All aeronautical specialties
  • Going for an expert aeromedical visit
  • Not opposing the study

Who cannot join

  • Presenting himself/herself for a first medical exam
  • Opposition to the study
  • Under 18 years of age
  • Non-professional aircrew
  • Pregnant woman, parturient, breastfeeding
  • Person deprived of liberty by a judicial or administrative decision, person undergoing psychiatric treatment by virtue of Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8
  • Adult person subject to a legal protection measure
  • Person unable to express consent

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Cempn, Hia Sainte Anne

    Toulon, Var, 83000

    Nicolas Huiban, MD, 04 83 16 22 65 ext. +33, nicolas.huiban@intradef.gouv.fr

    Recruiting

Other trials in France

About this study

Official title: Prevalence and Factors Associated With Insomnia and Sleep Time in a Sample of Professional Flight Members

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.

Read the detailed 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
Being tested
Sleeping condition self-questionnaire
Keywords
Sleeping time, Chronic insomnia, Sleepiness, Flight members
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleepiness

What participants receive

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

  • Sleeping condition self-questionnaireOther

    Professional flight members will answer a self questionnaire related to their sleeping conditions

Study groups in NCT04761796
Study groupRoleWhat they receive
Professional flight membersNot described
Receives: Other: Sleeping condition self-questionnaire

What is being measured

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

  1. To describe the average sleep time within a sample of the French professional flight members

    Average total nighttime sleep time estimated using a self-administered questionnaire

    Measured: 30 minutes

Secondary outcomes (6)
  1. Chronic insomnia

    Criteria of the International Classification of Sleep Disease (ICSD-3) of the American Academy of Sleep Medicine (items A, B and C of the questionnaire)

    Measured: 30 minutes

  2. Subjective excessive sleepiness Subjective excessive sleepiness

    Subjective excessive sleepiness will be estimated on the basis of the replies to the questionnaire : items of Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.

    Measured: 30 minutes

  3. Sleep duration, sleep debt, sleep restriction

    Sleep duration, sleep debt, sleep restriction will be estimated on the basis of the replies to the questionnaire

    Measured: 30 minutes

  4. Ideal sleep time

    Ideal sleep time will be estimated on the basis of the replies to the questionnaire

    Measured: 30 minutes

  5. Sociodemographic factors

    Sociodemographic factors will be estimated on the basis of the replies to the questionnaire Predictive factors of sleep duration, sleepiness and chronic insomnia will be assessed using a top-down liner and/or logistic models taking into account socio-demographic variables

    Measured: 30 minutes

  6. Aeronautical factors

    Aeronautical factors will be estimated on the basis of the replies to the questionnaire Predictive factors of sleep duration, sleepiness and chronic insomnia will be assessed using a top-down liner and/or logistic models taking into account occupational variables

    Measured: 30 minutes

Timeline

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

  1. First posted21 Feb 2021
  2. Study start26 Oct 2021
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04761796
Sponsor's protocol ID
2020-A02069-30
Acronym
SOMNAVI
Status last verified
Mar 2022
First submitted
16 Feb 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Insomnia and Sleepiness, run by Direction Centrale du Service de Santé des Armées 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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?

Results are not available in the source record.

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

Contact Nicolas Huiban, MD (04 83 16 22 65 ext. +33, nicolas.huiban@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe the average sleep time within a sample of the French professional flight members (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Mar 2022.

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