Obstructive Sleep ApneaNCT05039528
Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers
A study testing Personalized OSA messages in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Personalized OSA messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older
- Access to a smartphone device
- Commitment to completing all study activities
- Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.
Who cannot join
- Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
- No OSA risk (a score below 4 on the ARES).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Design and Usability Testing of a Tailored Intervention to Increase Awareness About Sleep and Sleep Disorders Among Transportation Workers
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.
Read the detailed description
Transportation shift workers (TSW, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). Also, TSW are at risk for obstructive sleep apnea (OSA). According to one study, approximately 36% of TSWs have OSA, a condition that exacerbates health risks and daytime sleepiness. A recent report from the American Academy of Sleep Medicine (AASM) showed that those with untreated OSA cost on average $4,261 more than those without OSA. Also concerning, workers with OSA who are non-adherent to recommended OSA treatment (i.e., continuous positive airway pressure, CPAP) are at particularly high risk for motor vehicle accidents compared to those who are adherent.
This protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about OSA among TSW. Results of these focus groups will be used in future research to design a tailored website for relaying OSA information to TSW.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Personalized OSA messages, Control
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized OSA messagesBehavioural
Participants will receive personalized OSA messages designed to nudge and navigate them toward evaluation and treatment for OSA. Participants will complete questionnaires at baseline and at study follow-up.
ControlOther
Participants will complete questionnaires at baseline and at study follow-up. At the end of the study period, participants will receive the OSA message intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the personalized OSA messages. Receives: Behavioral: Personalized OSA messages |
| Control | Placebo comparator | Placebo participants will receive no treatment during the experiment. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Sleep Apnea (OSA) Self-efficacy
The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Self-Efficacy subscale collects responses to 5 self-efficacy questions on 3-point scales from 1 "I am confident" to 2 "I am not sure" and 3 "I am not confident." Scores of 1 ("I am confident") indicate self-efficacy. To score OSA Self-Efficacy, the total number of questions that participants mark a response of "1" ("I am confident") are summed then divided by the total number of questions in the subscale (5) and multiplied by 100. The result is a total score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate low OSA self-efficacy scores. Higher scores (closer to 100%) indicate higher OSA Self-efficacy.
Measured: Baseline and follow-up (approximately 2 months)
Secondary outcomes (2)
OSA Knowledge
The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Knowledge subscale collects responses to 13 knowledge questions on 3-point scale from 1 ("I am confident this is true") to 2 ("I am not sure") and 3 ("I am confident this is not true"). To score OSA Knowledge, the total number of responses of 1 "I am confident this is true" are summed then divided by 13 and multiplied by 100. The result is a score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate lower OSA knowledge while higher scores (closer to 100%) indicate higher OSA Knowledge.
Measured: Baseline and follow-up (approximately 2 months)
OSA Readiness to Change
OSA Readiness to Change: A measure of willingness to improve sleep and address sleep problems. OSA readiness to change will be measured with a 12-item questionnaire. Responses are captured on a 5-item scale from 1 "strongly disagree" to 5 "strongly agree." Responses are summed for a total score of readiness to change. Higher scores indicate higher levels of readiness to change.
Measured: Baseline and follow-up (approximately 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Oct 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-month pre-post pilot study will be conducted. Two worksites will be selected at random then randomized to either the tailored (intervention) or non-tailored (control) groups. Participants who fit the eligibility criteria will be recruited from each worksite and assigned to the study arm corresponding to their worksite (20 per worksite for a total of 40 participants).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rebecca Robbins, Brigham and Women's Hospital
- Investigators
- Rebecca Robbins, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039528
- Sponsor's protocol ID
- 2019P003171
- Other IDs
- K01HL150339
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2021
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Usability Testing of a Tailored Intervention to Increase Awareness About Sleep and Sleep Disorders Among Transportation Workers
- ClinicalTrials.gov ID
- NCT05039528
- Acronym / sponsor ID
- 2019P003171
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.
Detailed description
Transportation shift workers (TSW, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). Also, TSW are at risk for obstructive sleep apnea (OSA). According to one study, approximately 36% of TSWs have OSA, a condition that exacerbates health risks and daytime sleepiness. A recent report from the American Academy of Sleep Medicine (AASM) showed that those with untreated OSA cost on average $4,261 more than those without OSA. Also concerning, workers with OSA who are non-adherent to recommended OSA treatment (i.e., continuous positive airway pressure, CPAP) are at particularly high risk for motor vehicle accidents compared to those who are adherent.
This protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about OSA among TSW. Results of these focus groups will be used in future research to design a tailored website for relaying OSA information to TSW.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A 2-month pre-post pilot study will be conducted. Two worksites will be selected at random then randomized to either the tailored (intervention) or non-tailored (control) groups. Participants who fit the eligibility criteria will be recruited from each worksite and assigned to the study arm corresponding to their worksite (20 per worksite for a total of 40 participants).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Personalized OSA messagesParticipants will receive the personalized OSA messages. |
| Control | Placebo comparator | Other: ControlPlacebo participants will receive no treatment during the experiment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Access to a smartphone device
- Commitment to completing all study activities
- Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.
Key exclusion criteria (2 listed)
- Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
- No OSA risk (a score below 4 on the ARES).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized OSA messagesParticipants will receive personalized OSA messages designed to nudge and navigate them toward evaluation and treatment for OSA. Participants will complete questionnaires at baseline and at study follow-up. | Behavioural | Intervention |
| ControlParticipants will complete questionnaires at baseline and at study follow-up. At the end of the study period, participants will receive the OSA message intervention. | Other | Control |
Primary outcome
Obstructive Sleep Apnea (OSA) Self-efficacy
Time frame: Baseline and follow-up (approximately 2 months)
The Survey of Obstructive Sleep Apnea Functional Health Literacy (SOFHL) was administered, which includes two subscales, one for OSA Self-Efficacy and another for OSA Knowledge. The SOFHL can be scored by measuring the proportion of correct answers in each sub-scale (OSA Self-Efficacy and OSA Knowledge). The OSA Self-Efficacy subscale collects responses to 5 self-efficacy questions on 3-point scales from 1 "I am confident" to 2 "I am not sure" and 3 "I am not confident." Scores of 1 ("I am confident") indicate self-efficacy. To score OSA Self-Efficacy, the total number of questions that participants mark a response of "1" ("I am confident") are summed then divided by the total number of questions in the subscale (5) and multiplied by 100. The result is a total score with a minimum possible value of 0% and a maximum possible value of 100%. Lower scores (closer to 0%) indicate low OSA self-efficacy scores. Higher scores (closer to 100%) indicate higher OSA Self-efficacy.
2 secondary outcomes
OSA Knowledge
Time frame: Baseline and follow-up (approximately 2 months)
OSA Readiness to Change
Time frame: Baseline and follow-up (approximately 2 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rebecca Robbins, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized OSA messages in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.
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 4 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 2 Oct 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (OSA) Self-efficacy (time frame: Baseline and follow-up (approximately 2 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 2 Oct 2026.