Personalised Active Self-management of Sleep Apnea Program (PASS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Behavioral: Control group; Behavioral: 4-month Personalized and Adaptive Sleep Support program (PASS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuen Kwan Agnes Lai, PhD; Phone Number: (852)3970-2917; Email: ayklai@hkmu.edu.hk
• Study Contact Backup: Name: On Chu George Cheung, MPhil; Phone Number: (852)3970-2933; Email: occheung@hkmu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years and above
• Newly diagnosed with OSA (diagnosis made within the past year)
• Newly started or not yet started Positive Airway Pressure (PAP) treatment, with a treatment duration of less than 6 months
• Physically inactive (self-reported moderate physical activity per week of <150 minutes)
• Overweight (BMI≥23 kg/m2)
• Mentally, cognitively, and physically fit to join the trial as determined by the doctor in charge and responsible clinical investigators
• Able to speak, read, and write Chinese
• Willing to complete the questionnaires and assessments
• Has a smartphone

Exclusion Criteria:

• Clinically significant psychiatric disorder
• Use of prescription drugs or clinically significant drugs affecting sleep.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Participants will receive a 4-month general hygiene information.	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
Experimental: Intervention group; Subjects in this arm will receive a 4-month digital Personalized and Adaptive Sleep Support program (PASS).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAP uptake	Whether the patient start to use the PAP therapy	Baseline, 2 months and 4 months
Program feasibility and acceptability	Evaluated via semi-structured interviews	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAP adherence - Intention to use	The percentage of days on which CPAP has been switched on (ie, total number of switch-on days divided by the total number of study days).	Baseline, 2 months and 4 months
PAP adherence - mean daily usage	The total number of hours of mask on divided by the total number of study days, which was downloaded with software	Baseline, 2 months and 4 months
PAP adherence - Usage Index	The percentage of days using CPAP for at least 4 h/d (ie, total number of such CPAP days divided by the total number of study days).	Baseline, 2 months and 4 months
Self-efficacy in self-management and treatment adherence	Measured by a 26-item Self-efficacy Measure for Sleep Apnea, with 3 subscales: the perceived risk of obstructive sleep apnea, CPAP outcome expectations, and treatment self-efficacy. High scores on the perceived risk scale denote greater perceived risks of OSA; high scores on the outcome expectations scale denote more positive beliefs about treatment; high scores on the treatment self-efficacy scale denote a greater willingness to engage in CPAP treatment despite certain obstacles.	Baseline, 2 months and 4 months
Exercise and dietary control self-efficacy	Measured by 2-item outcome-based questionnaire	Baseline, 2 months and 4 months
Dietary habits	Measured by a 10-item dietary intake and practice questionnaire	Baseline, 2 months and 4 months
Physical activity level	Measured by an 4-item International Physical Assessment Questionnaire - short version	Baseline, 2 months and 4 months
Steps count	Measured by an activity trackers	Baseline, 2 months and 4 months
Daytime sleepiness	Measured by an 8-item Epworth Sleepiness Scale. Higher score indicates more sleepy during daytime	Baseline, 2 months and 4 months
Sleep quality	Measured by a 7-item Insomnia Severity Index. Higher scores indicates poorer sleep quality	Baseline, 2 months and 4 months
Quality of life	Measured by a 10-item Functional Outcomes of Sleep Questionnaire and a 5-item EuroQol 5-Dimension questionnaire. Higher score indicates better quality of life	Baseline, 2 months and 4 months
Waist circumference	Measured by measuring tape	Baseline and 4 months
Body mass index	Calculated by height and weight	Baseline and 4 months
Body fat composition	Measured by bioimpedance scale	Baseline and 4 months
Blood pressure	Measured by sphygmomanometer	Baseline and 4 months
Severity of sleep apnoea	Measured by a Home-sleep test	Baseline and 4 months

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University
• Collaborators: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: Yuen Kwan Agnes Lai, PhD, Hong Kong Metropolitan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: self-management; OSA; digital health
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: UW 25-460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It has not been mentioned during the IRB application

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No