NCT04761796

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 16, 2021

Last Update Submit

March 17, 2022

Conditions

Chronic InsomniaSleepiness

Keywords

Sleeping timeChronic insomniaSleepinessFlight members

Outcome Measures

Primary Outcomes (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

    30 minutes

Secondary Outcomes (6)

  • Chronic insomnia

    30 minutes

  • Subjective excessive sleepiness Subjective excessive sleepiness

    30 minutes

  • Sleep duration, sleep debt, sleep restriction

    30 minutes

  • Ideal sleep time

    30 minutes

  • Sociodemographic factors

    30 minutes

  • +1 more secondary outcomes

Study Arms (1)

Professional flight members

Other: Sleeping condition self-questionnaire

Interventions

Sleeping condition self-questionnaireOTHER

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

Professional flight members

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of military aircrew.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cempn, Hia Sainte Anne

Toulon, Var, 83000, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleepiness

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Huiban, MD

    French Army Health Services

    STUDY DIRECTOR

Central Study Contacts

Nicolas Huiban, MD

CONTACT

04 83 16 22 65nicolas.huiban@intradef.gouv.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

October 26, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)