Obstructive Sleep Apnea (OSA)PASSNCT07494292
Personalised Active Self-management of Sleep Apnea Program
A study testing 4-month Personalized and Adaptive Sleep Support program (PASS) in people with Obstructive Sleep Apnea (OSA), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- 4-month Personalized and Adaptive Sleep Support program (PASS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Able to speak, read, and write Chinese
- Willing to complete the questionnaires and assessments
- Has a smartphone
Who cannot join
- Clinically significant psychiatric disorder
- Use of prescription drugs or clinically significant drugs affecting sleep.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Queen Mary Hopsital
Hong Kong
Agnes Yuen-Kwan Lai, PhD, 39702917, ayklai@hkmu.edu.hk
George Cheung, MPhil, 39702917, occheung@hkmu.edu.hk
About this study
Official 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
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.
Read the 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 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 and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline 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)
- Being tested
- 4-month Personalized and Adaptive Sleep Support program (PASS), Control group
- Keywords
- self-management, OSA, digital health
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-month Personalized and Adaptive Sleep Support program (PASS)Behavioural
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 groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| General Hygiene Control group | Active comparator | Participants will receive a 4-month general hygiene information. Receives: Behavioral: Control group |
| PASS Intervention group | Experimental | Subjects in this arm will receive a 4-month digital Personalized and Adaptive Sleep Support program (PASS). Receives: Behavioral: 4-month Personalized and Adaptive Sleep Support program (PASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive airway pressure (PAP) therapy uptake
Whether the patient start to use the PAP therapy. Answer option: Yes or No
Measured: Baseline and 4 months
Program feasibility and acceptability
Evaluated via semi-structured interviews
Measured: 4 months
Secondary outcomes (14)
Positive airway pressure therapy 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). Scores ranged from 0% to 100%. The high scores denote the better PAP use.
Measured: Baseline and 4 months
Positive airway pressure therapy 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. Scores ranged from 0 to 24 hours. The high scores denote the better PAP use.
Measured: Baseline and 4 months
Positive airway pressure therapy adherence - Usage Index
The percentage of days using PAP for at least 4 h/d (ie, total number of such PAP days divided by the total number of study days). Scores ranged from 0% to 100%. The high scores denote the better PAP use.
Measured: Baseline 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 sleep apnea, PAP outcome expectations, and treatment self-efficacy. Scores of subscale ranged from 1 to 4. Higher scores indicate greater perceived self-efficacy, greater perceived response efficacy, and higher perceived susceptibility.
Measured: Baseline and 4 months
Dietary habits
Measured by a 10-item outcome-based dietary practice questionnaire. Scores ranged from 1 to 5. The higher scores indicate the worse dietary practice.
Measured: Baseline and 4 months
Physical activity level
Measured by an 4-item International Physical Assessment Questionnaire - short version. Ranged from 0 to 24 hours per day. The higher scores represent higher physical activity level.
Measured: Baseline and 4 months
Daytime sleepiness
Measured by an 8-item Epworth Sleepiness Scale. Scores ranged from 0 to 24. Higher scores indicate more sleepy during daytime.
Measured: Baseline and 4 months
Sleep quality
Measured by a 7-item Insomnia Severity Index. Higher scores indicate poorer sleep quality
Measured: Baseline and 4 months
Quality of life
Measured by a 10-item Functional Outcomes of Sleep Questionnaire. Total scores ranged from 5 to 20. The higher scores indicate better functional status.
Measured: Baseline and 4 months
Waist circumference
Measured by measuring tape
Measured: Baseline and 4 months
Body mass index
Calculated by height and weight
Measured: Baseline and 4 months
Body fat composition
Measured by bioimpedance scale
Measured: Baseline and 4 months
Severity of sleep apnoea
Measured by a Home-sleep test
Measured: Baseline and 4 months
Technology acceptance
Measured by a 7-item modified Technology acceptance model questionnaire. Ranged 1 to 7 for each item. Higher scores indicate better acceptance.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start3 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Professor Agnes LAI Yuen Kwan, Hong Kong Metropolitan University
- Investigators
- Yuen Kwan Agnes Lai, PhD, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494292
- Sponsor's protocol ID
- UW 25-460
- Acronym
- PASS
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has not been mentioned during the IRB application
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07494292
- Acronym / sponsor ID
- PASS / UW 25-460
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- self-management, OSA, digital health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Hygiene Control group | Active comparator | Behavioral: Control groupParticipants will receive a 4-month general hygiene information. |
| PASS Intervention group | Experimental | Behavioral: 4-month Personalized and Adaptive Sleep Support program (PASS)Subjects in this arm will receive a 4-month digital Personalized and Adaptive Sleep Support program (PASS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (2 listed)
- Clinically significant psychiatric disorder
- Use of prescription drugs or clinically significant drugs affecting sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PASS Intervention group |
| Control groupParticipants 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 | Behavioural | General Hygiene Control group |
Primary outcome
Positive airway pressure (PAP) therapy uptake
Time frame: Baseline and 4 months
Whether the patient start to use the PAP therapy. Answer option: Yes or No
Program feasibility and acceptability
Time frame: 4 months
Evaluated via semi-structured interviews
14 secondary outcomes
Positive airway pressure therapy adherence - Intention to use
Time frame: Baseline and 4 months
Positive airway pressure therapy adherence - mean daily usage
Time frame: Baseline and 4 months
Positive airway pressure therapy adherence - Usage Index
Time frame: Baseline and 4 months
Self-efficacy in self-management and treatment adherence
Time frame: Baseline and 4 months
Dietary habits
Time frame: Baseline and 4 months
Physical activity level
Time frame: Baseline and 4 months
Daytime sleepiness
Time frame: Baseline and 4 months
Sleep quality
Time frame: Baseline and 4 months
Quality of life
Time frame: Baseline and 4 months
Waist circumference
Time frame: Baseline and 4 months
Body mass index
Time frame: Baseline and 4 months
Body fat composition
Time frame: Baseline and 4 months
Severity of sleep apnoea
Time frame: Baseline and 4 months
Technology acceptance
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. It has not been mentioned during the IRB application
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuen Kwan Agnes Lai, PhD principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-month Personalized and Adaptive Sleep Support program (PASS) in people with Obstructive Sleep Apnea (OSA), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuen Kwan Agnes Lai, PhD ((852)3970-2917, ayklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive airway pressure (PAP) therapy uptake (time frame: Baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.