OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT05175287
• Lead Sponsor: Respiralab

Brief Summary

Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a sample of Ecuadorian bus drivers.

Detailed Description

We conducted a cross-sectional study from September 2019 to January 2020 among 340 male professional bus drivers in the city of Guayaquil, Ecuador. To be included in the study, participants were required to be male, have an unexpired professional driver's license, as well as being currently enrolled at any local transformational company. Individuals who did not met the inclusion criteria, or who declined voluntary participation were excluded from the study. We screened 340 male professional bus drivers whose mean age was 44.3. We analyzed demographic and clinical variables including age, educational level, associated comorbidities (hypertension and diabetes), years as a professional driver, and number of accidents and near-accidents while working. Accidents were defined as a collision involving the vehicle in which the participant was the driver and another vehicle or stationary obstruction. Near-accidents were defined as unplanned events involving the driver that did not result in injury but had the potential to do so. We used STOP questionnaire to assess four questions related to snoring, tiredness during daytime, observed apnea, and high blood pressure (STOP), and the Bang aspect for screening BMI ≥ 35, age ≥ 50, neck circumference \> 40 cm and male gender. Also, we used Epworth Sleepiness Scale (ESS) to assess excessive daytime sleepiness (EDS).

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-15
• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-03
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 340

Inclusion Criteria

• Male
• Have an unexpired professional driver's license
• Being currently enrolled at any local transformational company

Exclusion Criteria

• Not meeting inclusion criteria
• Declined voluntary participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obstructive sleep apnea	4 months	STOP-Bang questionnaire: assesses four questions related to snoring, tiredness during daytime, observed apnea, and high blood pressure (STOP), while the Bang aspect screens for a BMI ≥ 35, age ≥ 50, neck circumference \> 40 cm and male gender.

Secondary Outcome Measures

Name	Time	Method
Excessive daytime sleepiness (EDS)	4 months	Epworth Sleepiness Scale (ESS): self-administered questionnaire, with 8 questions in which individuals are asked to rate the likelihood of falling asleep while engaged in different activities using a 4-point scale.

Trial Locations

Locations (1)

Respiralab Research Group; 🇪🇨 Guayaquil, Guayas, Ecuador