Clinical Trial

Personalised Active Self-management of Sleep Apnea Program

Study acronym: PASS
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Summary
This study is to assess the feasibility and acceptability of the PASS in patients with OSA. Second, the study examines its effectiveness in improving PAP uptake and adherence, self-efficacy in self-care, changes in health-related habits, and health outcomes. We also assess the facilitators and barriers to implementing the PASS. This is a two-group pilot randomized controlled trial (n=60) with a 4-month follow-up. Subjects assigned to the intervention group will receive a 4-month Personalized and Adaptive Sleep Support (PASS) program, a digital platform-based intervention. The 4-month program incorporates: i) a 20-minute brief motivational interviewing session; ii) a digital platform where users can view personalized OSA health-related videos and information, track their adherence to prescribed treatments, log their daily activities and dietary intake, and set personal health goals; and iii) continuous personalized chat-based messaging and phone call support. Participants in the control group will receive a 4-month general hygiene program, including (i) a 20-minute session, (ii) messaging, and (iii) phone call support. The feasibility and acceptability of the PASS will be evaluated via semi-structured interviews at the 4-month follow-up. Self-administered questionnaires will be used at baseline and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 4-month follow-ups. PAP adherence data will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and at month 4.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-07
notable Primary completion pushed: 2026-12-31 -> 2027-03-31 2026-08-07
minor Completion pushed: 2027-03-31 -> 2027-06-30 2026-08-07
Trial Details
NCT Number NCT07494292
Lead Sponsor Hong Kong Metropolitan University
Collaborators: Queen Mary Hospital, Hong Kong
Conditions Obstructive Sleep Apnea (OSA)
Enrollment 60 participants
Start Date 2026-08-03
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06