NCT07494292

Personalised Active Self-management of Sleep Apnea Program

A Personalised Active Self-management of Sleep Apnea Program (PASS) to Improve Positive Airway Pressure Treatment Uptake and Adherence: A Pilot Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hong Kong Metropolitan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 2- and 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.

Detailed description

This is a two-group pilot randomised control trial with a 4-month follow-up. Forty subjects (30 for the intervention group and 30 for the control group) will be recruited Subject. Subjects in intervention group will receive a 4-month Personalized and Adaptive Sleep Support Program (PASS), a digital platform-based intervention guided by social cognitive theory and use brief motivational interviewing (brief MI) to enhance subjects' psychological capacity and motivation, feel confident in managing chronic situations, and provide continuous individual support. The PASS is a 4-month program utilizing a multimodal approach with three main components: i) A 20-Minute Brief Motivational Interviewing Session, ii) a digital platform, and iii) a continuous personalized chat-based messaging and phone call support. The 20-minute interviewing session utilizes Motivational Interviewing (MI) techniques to engage and motivate participants in managing their OSA. The digital platform providing multiple functions for OSA subjects, including self-selection of personalised OSA health-related videos and information, tracking Positive airway pressure treatment adherence, physical activity levels, diet, sleep habits, body weight, blood pressure, and setting personal health goals. The continuous personalized chat-based messaging and phone call support provides ongoing, tailored support and encouragement through messaging, helping to engage and adhere to the program. Participants receive additional support through regular phone calls, offering a more personal touch and the opportunity to address any specific concerns or challenges they may be facing. Participants in control group will receive a 4-month general hygiene program, including (i) A 20-minute session, (ii) messaging, and (iii) phone call support. Program feasibility and acceptability will be evaluated via semi-structured interviews at 4 months, while primary outcomes (PAP uptake) and secondary outcomes (including PAP adherence, self-efficacy, health-related habits, and quality of life) will be measured using a combination of self-administered questionnaires (e.g., SEMSA, ESS, ISI), objective activity trackers, and data retrieved from PAP machines at baseline, 2 months, and 4 months, with clinical outcomes like BMI and OSA severity assessed at baseline and the 4-month follow-up. Self-administered questionnaires will be used at baseline, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline, 2-, and 4-month follow-up. PAP adherence will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and month 4. Individual interviews will be conducted after a 4-month program. The aims are to (i) explore subjects' perception and satisfaction with the programme, (ii) understand the impacts and extent to which the changes have sustained and integrated into their daily life; and (iii) identify elements of the programme they view as helpful/unhelpful in supporting them to increase self-management ability, (iv) explore the facilitators and barriers for exercise adherence. If subjects withdraw from the assessment or drop out of the programme, they will not be asked for the reasons, and it will not affect the current treatment and follow-up.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
BEHAVIORAL	4-month Personalized and Adaptive Sleep Support program (PASS)	The 4-month Personalized and Adaptive Sleep Support (PASS) program incorporate 3 components: i) 20-minute brief motivational interviewing Session motivating participants, ii) digital platformThe digital platform enabling participants to access tailored health content, track PAP therapy adherence, log physical data such as activity and diet, and utilize integrated tools for self-monitoring and goal setting, iii) continuous personalized support offering chat-based messaging to promote program engagement and adherence.
BEHAVIORAL	Control group	Participants will receive a 4-month general hygiene program, including (i) A 20-minute session, (ii) messaging, and (iii) phone call support. The content focuses on hand hygiene and food hygiene

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-03-27
• Last updated: 2026-03-27