NCT05175287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

December 14, 2021

Last Update Submit

December 30, 2021

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep apneadaytime sleepinessaccidentsbus drivers

Outcome Measures

Primary Outcomes (1)

  • Obstructive sleep apnea

    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.

    4 months

Secondary Outcomes (1)

  • Excessive daytime sleepiness (EDS)

    4 months

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

340 male professional bus drivers whose mean age was 44.3 in the city of Guayaquil, Ecuador.

You may qualify if:

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

You may not qualify if:

  • Declined voluntary participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiralab Research Group

Guayaquil, Guayas, 090512, Ecuador

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

September 1, 2019

Primary Completion

January 31, 2020

Study Completion

February 15, 2020

Last Updated

January 3, 2022

Record last verified: 2021-12

Locations

EC(1)