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Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers

Design and Usability Testing of a Tailored Intervention to Increase Awareness About Sleep and Sleep Disorders Among Transportation Workers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05039528
Enrollment
38
Registered
2021-09-09
Start date
2022-10-01
Completion date
2024-07-01
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief 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.

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.

Interventions

BEHAVIORALPersonalized OSA messages

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.

OTHERControl

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention 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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Age 18 years or older 2. Access to a smartphone device 3. Commitment to completing all study activities 4. Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.

Exclusion criteria

1. Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12) 2. No OSA risk (a score below 4 on the ARES).

Design outcomes

Primary

MeasureTime frameDescription
Change in OSA self-management efficacy as measured by the Survey of OSA Functional Health Literacy (SOFHL)The SOFHL will be administered at baseline and post-intervention. Change in SOFHL score on self-management efficacy will be computed by comparing responses at baseline and post-intervention.OSA self-management efficacy will be examined using the SOFHL

Secondary

MeasureTime frameDescription
Change in OSA general knowledge as measured by the SOFHL.The SOFHL will be administered at baseline and post-intervention. Change in SOFHL score on OSA general knowledge will be computed by comparing responses at baseline and post-intervention.OSA general knowledge will be assessed with the validated SOFHL.
Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).Sleepiness will be assessed at baseline and post-intervention. Change in daytime sleepiness will be computed by comparing responses at baseline and post-intervention..Daytime sleepiness will be assessed with the validated ESS.
Change in Attentional Failures as measured by previously validated questions assessing Attentional Failures.Attentional failures will be measured at baseline and post-intervention.Change in attentional failures will be computed by comparing responses at baseline and follow-up.Attentional failures (e.g., near miss accidents) will be measured via self-report.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026