NCT03644758

Brief Summary

Studies have shown that schedules that most disrupt the normal circadian rhythm have the most harmful consequences. Firefighters positive for a sleep disorder have a higher risk of depression and anxiety; they report more traffic accidents, falling asleep during driving, and worth health felt. Furthermore, some studies suggest that sleep disorders are risk factors for cardiovascular disease. This activity is responsible of a worth quality of sleep that could induce a lower effectiveness of emergency response. The consequences of this schedules on sleep and health of French firemen have never been studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

August 22, 2018

Last Update Submit

November 20, 2019

Conditions

Firefighter

Keywords

FirefighterSleepSleep disordersPittsburgh Sleep Quality Index (PSQI)Epworth Sleepiness ScaleInsomnia Severity Index (ISI)stop-BANG questionnaire

Outcome Measures

Primary Outcomes (1)

  • sleep disturbances

    Analyzed the percentage of firefighters with a score greater than 5 on the self-administrated questionnaire Pittsburgh Sleep Quality Index (PSQI) (Buysse and al., 1989). This score evaluates sleep disturbances.

    September 2019

Secondary Outcomes (12)

  • excessive drowsiness

    September 2019

  • insomnia severity

    September 2019

  • Obstructive Sleep Apnea (OSA)

    September 2019

  • status firefighter

    September 2019

  • number of years of professional practice

    September 2019

  • +7 more secondary outcomes

Study Arms (1)

professional and voluntary firefighter

Professional and voluntary firefighter in Service Departmental Fire and Rescue of Loire will be included. They will have to answer at the self-administrated questionnaires. It is composed of 5 parts: socio-demographic data and personal medical history, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Insomnia Severity Index (ISI) and stop-BANG questionnaire.

Diagnostic Test: socio-demographic data and personal medical historyDiagnostic Test: Pittsburgh Sleep Quality Index (PSQI)Diagnostic Test: Epworth Sleepiness ScaleDiagnostic Test: Insomnia Severity Index (ISI)Diagnostic Test: stop-BANG questionnaire

Interventions

socio-demographic data and personal medical historyDIAGNOSTIC_TEST

Socio-demographic data and personal medical history is a self-administered questionnaire.

professional and voluntary firefighter
Pittsburgh Sleep Quality Index (PSQI)DIAGNOSTIC_TEST

Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire. This score evaluates sleep disturbances.

professional and voluntary firefighter
Epworth Sleepiness ScaleDIAGNOSTIC_TEST

Epworth Sleepiness Scale is a self-administered questionnaire. This score evaluates excessive drowsiness.

professional and voluntary firefighter
Insomnia Severity Index (ISI)DIAGNOSTIC_TEST

Insomnia Severity Index (ISI) is a self-administered questionnaire. This score evaluates insomnia severity.

professional and voluntary firefighter
stop-BANG questionnaireDIAGNOSTIC_TEST

Stop-BANG is a self-administered questionnaire. This score evaluates Obstructive Sleep Apnea (OSA).

professional and voluntary firefighter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Professional or voluntary firefighter will be included.

You may qualify if:

  • Any professional or voluntary firefighter active in Service Departmental Fire and Rescue of Loire or in retirement, and also the medical and paramedical staff of Service Departmental Fire and Rescue of Loire.
  • Any fireman affiliated to a social security regime.
  • Any fireman who has received information from the study and has agreed to participate in the study.

You may not qualify if:

  • Any fireman unable to understand the study.
  • Any fireman having a legal protection measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Frédéric ROCHE, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 23, 2018

Study Start

November 27, 2018

Primary Completion

May 14, 2019

Study Completion

May 14, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)