Firefighter Clinical Trial
— FIRESLEEPOfficial title:
Assessment of the Quality of Sleep and Sleep Disorders Among the Professional and Volunteer Firefighters of Loire
| NCT number | NCT03644758 |
| Other study ID # | 18CH087 |
| Secondary ID | ANSM |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 27, 2018 |
| Est. completion date | May 14, 2019 |
| Verified date | November 2019 |
| Source | Centre Hospitalier Universitaire de Saint Etienne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 196 |
| Est. completion date | May 14, 2019 |
| Est. primary completion date | May 14, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Saint-Etienne | Saint-Étienne |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |
September 2019 | |
| Secondary | 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. |
September 2019 | |
| Secondary | 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). |
September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 | |
| Secondary | 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. | September 2019 |
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|---|---|---|---|
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