FirefighterFIRESLEEPNCT03644758
Assessment of the Quality of Sleep and Sleep Disorders Among the Professional and Volunteer Firefighters of Loire
An observational study of Firefighter, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Firefighter
- What is being tested?
- socio-demographic data and personal medical history, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2018to 14 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professional or voluntary firefighter will be included.
Who may be able to join
- 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.
Who cannot join
- Any fireman unable to understand the study.
- Any fireman having a legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In this context, the objective of this observational epidemiological study is to evaluate the quality of sleep of the firefighters of Loire.
- Conditions
- Firefighter
- Being tested
- socio-demographic data and personal medical history, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Insomnia Severity Index (ISI), stop-BANG questionnaire
- Keywords
- Firefighter, Sleep, Sleep disorders, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Insomnia Severity Index (ISI), stop-BANG questionnaire
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socio-demographic data and personal medical historyDiagnostic test
Socio-demographic data and personal medical history is a self-administered questionnaire.
Pittsburgh Sleep Quality Index (PSQI)Diagnostic test
Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire. This score evaluates sleep disturbances.
Epworth Sleepiness ScaleDiagnostic test
Epworth Sleepiness Scale is a self-administered questionnaire. This score evaluates excessive drowsiness.
Insomnia Severity Index (ISI)Diagnostic test
Insomnia Severity Index (ISI) is a self-administered questionnaire. This score evaluates insomnia severity.
stop-BANG questionnaireDiagnostic test
Stop-BANG is a self-administered questionnaire. This score evaluates Obstructive Sleep Apnea (OSA).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: socio-demographic data and personal medical history; Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Epworth Sleepiness Scale; Diagnostic Test: Insomnia Severity Index (ISI); Diagnostic Test: stop-BANG questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2019
Secondary outcomes (12)
excessive drowsiness
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.
Measured: September 2019
insomnia severity
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.
Measured: September 2019
Obstructive Sleep Apnea (OSA)
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).
Measured: September 2019
status firefighter
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.
Measured: September 2019
number of years of professional practice
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.
Measured: September 2019
fire station
Correlation between fire station and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
Measured: September 2019
exercise of another professional activity
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.
Measured: September 2019
shift schedules 12 or 24 hours
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.
Measured: September 2019
family status
Correlation between shift family status and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
Measured: September 2019
personal medical history
Correlation between personal medical history and the scores of Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and stop-BANG.
Measured: September 2019
number of interventions by guard
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.
Measured: September 2019
number of interventions by constraint
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.
Measured: September 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start27 Nov 2018
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FirefighterStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644758
- Sponsor's protocol ID
- 18CH087
- Other IDs
- ANSM
- Acronym
- FIRESLEEP
- Status last verified
- Nov 2019
- First submitted
- 22 Aug 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Quality of Sleep and Sleep Disorders Among the Professional and Volunteer Firefighters of Loire
- ClinicalTrials.gov ID
- NCT03644758
- Acronym / sponsor ID
- FIRESLEEP / 18CH087
- Conditions
- Firefighter
- Keywords
- Firefighter, Sleep, Sleep disorders, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Insomnia Severity Index (ISI), stop-BANG questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this context, the objective of this observational epidemiological study is to evaluate the quality of sleep of the firefighters of Loire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| professional and voluntary firefighter | – | Diagnostic Test: socio-demographic data and personal medical history, Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI), Diagnostic Test: Epworth Sleepiness Scale, Diagnostic Test: Insomnia Severity Index (ISI), Diagnostic Test: stop-BANG questionnaireProfessional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional or voluntary firefighter will be included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Any fireman unable to understand the study.
- Any fireman having a legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| socio-demographic data and personal medical historySocio-demographic data and personal medical history is a self-administered questionnaire. | Diagnostic test | professional and voluntary firefighter |
| Pittsburgh Sleep Quality Index (PSQI)Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire. This score evaluates sleep disturbances. | Diagnostic test | professional and voluntary firefighter |
| Epworth Sleepiness ScaleEpworth Sleepiness Scale is a self-administered questionnaire. This score evaluates excessive drowsiness. | Diagnostic test | professional and voluntary firefighter |
| Insomnia Severity Index (ISI)Insomnia Severity Index (ISI) is a self-administered questionnaire. This score evaluates insomnia severity. | Diagnostic test | professional and voluntary firefighter |
| stop-BANG questionnaireStop-BANG is a self-administered questionnaire. This score evaluates Obstructive Sleep Apnea (OSA). | Diagnostic test | professional and voluntary firefighter |
Primary outcome
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.
12 secondary outcomes
excessive drowsiness
Time frame: September 2019
insomnia severity
Time frame: September 2019
Obstructive Sleep Apnea (OSA)
Time frame: September 2019
status firefighter
Time frame: September 2019
number of years of professional practice
Time frame: September 2019
fire station
Time frame: September 2019
exercise of another professional activity
Time frame: September 2019
shift schedules 12 or 24 hours
Time frame: September 2019
family status
Time frame: September 2019
personal medical history
Time frame: September 2019
number of interventions by guard
Time frame: September 2019
number of interventions by constraint
Time frame: September 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ROCHE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Firefighter, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep disturbances (time frame: September 2019). 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 21 Nov 2019.