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

September 30, 2026 updated by: Rebecca Robbins, Brigham and Women's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention

Participants will receive the personalized OSA messages.
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.
Placebo Comparator: Control

Placebo participants will receive no treatment during the experiment.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and follow-up (approximately 2 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OSA Knowledge
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 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.
Baseline and follow-up (approximately 2 months)
OSA Readiness to Change
Time Frame: Baseline and follow-up (approximately 2 months)

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.
Baseline and follow-up (approximately 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca Robbins, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P003171
  • K01HL150339 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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