Sleep Apnea, ObstructiveNCT05175287
OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
An observational study of Sleep Apnea, Obstructive, run by Respiralab at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 340 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Sep 2019to 15 Feb 2020
- How long will I take part?
- 4 Months
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 340 male professional bus drivers whose mean age was 44.3 in the city of Guayaquil, Ecuador.
Who may be able to join
- Male
- Have an unexpired professional driver's license
- Being currently enrolled at any local transformational company
Who cannot join
- Not meeting inclusion criteria
- Declined voluntary participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk 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.
Read the 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).
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, daytime sleepiness, accidents, bus drivers
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Disorders of Excessive Somnolence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Excessive daytime sleepiness (EDS)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Sep 2019
- Primary completion31 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 340 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Respiralab
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Especialidades Espiritu Santo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175287
- Sponsor's protocol ID
- 2021-MED-002
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
- ClinicalTrials.gov ID
- NCT05175287
- Acronym / sponsor ID
- 2021-MED-002
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, daytime sleepiness, accidents, bus drivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- RespiralabUniversity, hospital or other
- Collaborators
- Universidad de Especialidades Espiritu Santo
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 3 Jan 2022 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 340 male professional bus drivers whose mean age was 44.3 in the city of Guayaquil, Ecuador.
Key inclusion criteria (3 listed)
- Male
- Have an unexpired professional driver's license
- Being currently enrolled at any local transformational company
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria
- Declined voluntary participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Excessive daytime sleepiness (EDS)
Time frame: 4 months
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 3 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea, Obstructive, run by Respiralab at 1 site in Ecuador.
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 3 Jan 2022. 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 Ecuador. 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?
Obstructive sleep apnea (time frame: 4 months). 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 3 Jan 2022.