- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03644758
Assessment of the Quality of Sleep and Sleep Disorders Among the Professional and Volunteer Firefighters of Loire (FIRESLEEP)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-Étienne, France
- CHU Saint-etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any fireman unable to understand the study.
- Any fireman having a legal protection measure.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Socio-demographic data and personal medical history is a self-administered questionnaire.
Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire.
This score evaluates sleep disturbances.
Epworth Sleepiness Scale is a self-administered questionnaire.
This score evaluates excessive drowsiness.
Insomnia Severity Index (ISI) is a self-administered questionnaire.
This score evaluates insomnia severity.
Stop-BANG is a self-administered questionnaire.
This score evaluates Obstructive Sleep Apnea (OSA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep disturbances
Time Frame: September 2019
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
excessive drowsiness
Time Frame: September 2019
|
Analyzed the percentage of firefighters totalizing a score of 10 or more during the self-realization of the Epworth Sleepiness Scale (Johns 1991). This score evaluates excessive drowsiness. |
September 2019
|
insomnia severity
Time Frame: September 2019
|
Analyzed the percentage of firefighters totalizing a score of 10 on the auto-administrated questionnaire of Insomnia Severity Index (Bastien 2001). This score evaluates insomnia severity. |
September 2019
|
Obstructive Sleep Apnea (OSA)
Time Frame: September 2019
|
Analyzed the percentage of firefighters with a high-risk of obstructive sleep apnea syndrome on the STOP-Bang questionnaire (Chung et al., 2012). This score evaluates the risk of doing an Obstructive Sleep Apnea (OSA). |
September 2019
|
status firefighter
Time Frame: September 2019
|
Correlation between status firefighter (professional or voluntary firefighter) and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
number of years of professional practice
Time Frame: September 2019
|
Correlation between number of years of professional practice as a firefighter and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
fire station
Time Frame: September 2019
|
Correlation between fire station and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
exercise of another professional activity
Time Frame: September 2019
|
Correlation between exercise of another professional activity and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
shift schedules 12 or 24 hours
Time Frame: September 2019
|
Correlation between shift schedules 12 or 24 hours and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
family status
Time Frame: September 2019
|
Correlation between shift family status and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
personal medical history
Time Frame: September 2019
|
Correlation between personal medical history and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
number of interventions by guard
Time Frame: September 2019
|
Correlation between number of interventions by guard and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
number of interventions by constraint
Time Frame: September 2019
|
Correlation between number of interventions by constraint and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
|
September 2019
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frédéric ROCHE, PhD, CHU Saint-etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18CH087
- ANSM (Other Identifier: 2022-A02513-40)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Firefighter
-
Saglik Bilimleri UniversitesiCompletedRespiratory | Firefighter | ClimbingTurkey
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedFirefighter | High Cardiovascular RiskFrance
-
University of North Carolina, Chapel HillNational Institute for Occupational Safety and Health (NIOSH/CDC)Enrolling by invitationHigh Intensity Interval Training | FirefighterUnited States
-
University of VictoriaRecruitingInflammatory Response | Heat Stress, Exertional | Firefighter Personal Protective EquipmentCanada
Clinical Trials on socio-demographic data and personal medical history
-
Centre Hospitalier Universitaire DijonCompletedArrythmia -Myocardial InfarctionFrance
-
Memorial Sloan Kettering Cancer CenterTerminated
-
McDaniel Institute of Anti-Aging ResearchAllergan; Merz Aesthetics Inc.; ThermiGen, LLCUnknown
-
Assistance Publique - Hôpitaux de ParisCommissariat A L'energie Atomique; Institut National de Recherche pour l'Agriculture... and other collaboratorsCompleted
-
Cairo UniversityCompletedGenital ProlapseEgypt
-
Société des Produits Nestlé (SPN)CompletedNutrition Poor
-
University Hospital, Basel, SwitzerlandRecruitingLoss of Capability of JudgementSwitzerland
-
Peking University Third HospitalRecruitingLow Back Pain | Neck Pain | Shoulder PainChina
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedNonsmall Cell Lung Cancer | Nonsmall Cell Lung Cancer StageUnited States
-
Joslin Diabetes CenterActive, not recruiting