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NCT Number: NCT07494292

Personalised Active Self-management of Sleep Apnea Program

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. PAP uptake

    Time frame: Baseline, 2 months and 4 months

    Whether the patient start to use the PAP therapy

  2. Program feasibility and acceptability

    Time frame: 4 months

    Evaluated via semi-structured interviews

Secondary outcomes

  1. PAP adherence - Intention to use

    Time frame: Baseline, 2 months and 4 months

    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).

  2. PAP adherence - mean daily usage

    Time frame: Baseline, 2 months and 4 months

    The total number of hours of mask on divided by the total number of study days, which was downloaded with software

  3. PAP adherence - Usage Index

    Time frame: Baseline, 2 months and 4 months

    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).

  4. Self-efficacy in self-management and treatment adherence

    Time frame: Baseline, 2 months and 4 months

    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.

  5. Exercise and dietary control self-efficacy

    Time frame: Baseline, 2 months and 4 months

    Measured by 2-item outcome-based questionnaire

  6. Dietary habits

    Time frame: Baseline, 2 months and 4 months

    Measured by a 10-item dietary intake and practice questionnaire

  7. Physical activity level

    Time frame: Baseline, 2 months and 4 months

    Measured by an 4-item International Physical Assessment Questionnaire - short version

  8. Steps count

    Time frame: Baseline, 2 months and 4 months

    Measured by an activity trackers

  9. Daytime sleepiness

    Time frame: Baseline, 2 months and 4 months

    Measured by an 8-item Epworth Sleepiness Scale. Higher score indicates more sleepy during daytime

  10. Sleep quality

    Time frame: Baseline, 2 months and 4 months

    Measured by a 7-item Insomnia Severity Index. Higher scores indicates poorer sleep quality

  11. Quality of life

    Time frame: Baseline, 2 months and 4 months

    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

  12. Waist circumference

    Time frame: Baseline and 4 months

    Measured by measuring tape

  13. Body mass index

    Time frame: Baseline and 4 months

    Calculated by height and weight

  14. Body fat composition

    Time frame: Baseline and 4 months

    Measured by bioimpedance scale

  15. Blood pressure

    Time frame: Baseline and 4 months

    Measured by sphygmomanometer

  16. Severity of sleep apnoea

    Time frame: Baseline and 4 months

    Measured by a Home-sleep test

Study contacts

Contact information is provided by the study sponsor or research team.

On Chu George Cheung, MPhil

CONTACT

[email protected]

(852)3970-2933

Yuen Kwan Agnes Lai, PhD

CONTACT

[email protected]

(852)3970-2917

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Collaborators

  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Acronym: PASS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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