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OpenTrials
Completed

NCT Number: NCT05175287

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Obstructive sleep apnea

    Time frame: 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 outcomes

  1. Excessive daytime sleepiness (EDS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Respiralab

Other

Collaborators

  • Universidad de Especialidades Espiritu Santo

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2022
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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