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

NCT05039528 | Completed Results DMC

• 2 other identifiers: 2019P003171K01HL150339
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and follow-up (approximately 2 months)

Secondary Outcomes (2)

• OSA Knowledge

  Baseline and follow-up (approximately 2 months)

• OSA Readiness to Change

  Baseline and follow-up (approximately 2 months)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the personalized OSA messages.

Behavioral: Personalized OSA messages

Control

PLACEBO COMPARATOR

Placebo participants will receive no treatment during the experiment.

Other: Control

Interventions

Personalized OSA messages BEHAVIORAL

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Rebecca Robbins
• Organization: Brigham and Women's Hospital

rrobbins4@bwh.harvard.edu

617-732-5275

Study Officials

• Rebecca Robbins, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical Scool and Associate Scientist at Brigham & Women's Hospital

Model Details: 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).

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 2, 2026
• Results First Posted: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)