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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039528
• Other study ID #: 2019P003171
• Secondary ID: K01HL150339
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Parasomnias
• Sleep Apnea, Obstructive
• Sleep Wake Disorders

Intervention

Behavioral:
• Personalized 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.

Other:
• Control
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in OSA self-management efficacy as measured by the Survey of OSA Functional Health Literacy (SOFHL)	OSA self-management efficacy will be examined using the 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.
Secondary	Change in OSA general knowledge as measured by the SOFHL.	OSA general knowledge will be assessed with the validated 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.
Secondary	Change in Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS).	Daytime sleepiness will be assessed with the validated 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..
Secondary	Change in Attentional Failures as measured by previously validated questions assessing Attentional Failures.	Attentional failures (e.g., near miss accidents) will be measured via self-report.	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.