Personalised Active Self-management of Sleep Apnea Program

NCT07494292 | Not Yet Recruiting DMC

• 1 other identifier: UW 25-460
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

self-management; OSA; digital health

Outcome Measures

Primary Outcomes (2)

• Positive airway pressure (PAP) therapy uptake

  Whether the patient start to use the PAP therapy. Answer option: Yes or No

  Baseline and 4 months

• Program feasibility and acceptability

  Evaluated via semi-structured interviews

  4 months

Secondary Outcomes (14)

• Positive airway pressure therapy adherence - Intention to use

  Baseline and 4 months

• Positive airway pressure therapy adherence - mean daily usage

  Baseline and 4 months

• Positive airway pressure therapy adherence - Usage Index

  Baseline and 4 months

• Self-efficacy in self-management and treatment adherence

  Baseline and 4 months

• Dietary habits

  Baseline and 4 months

Study Arms (2)

General Hygiene Control group

ACTIVE COMPARATOR

Participants will receive a 4-month general hygiene information.

Behavioral: Control group

PASS Intervention group

EXPERIMENTAL

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)

Interventions

Control group BEHAVIORAL

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

General Hygiene Control group

4-month Personalized and Adaptive Sleep Support program (PASS) BEHAVIORAL

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.

PASS Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hopsital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yuen Kwan Agnes Lai, PhD

  Hong Kong Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen Kwan Agnes Lai, PhD

CONTACT

(852)3970-2917; ayklai@hkmu.edu.hk

On Chu George Cheung, MPhil

CONTACT

(852)3970-2933; occheung@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)