An interventional study of 4-month Personalized and Adaptive Sleep Support program (PASS) and Control group in Obstructive Sleep Apnea (OSA), sponsored by Hong Kong Metropolitan University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Hong Kong Metropolitan University · Not applicable, Interventional, and Supportive care
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hong Kong Metropolitan University is the lead sponsor of 56 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a 4-month general hygiene information.
Behavioral: Control 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.
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
Positive airway pressure (PAP) therapy uptake
Whether the patient start to use the PAP therapy. Answer option: Yes or No
Time frame: Baseline and 4 months
Program feasibility and acceptability
Evaluated via semi-structured interviews
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 months
Sleep quality
Measured by a 7-item Insomnia Severity Index. Higher scores indicate poorer sleep quality
Time frame: 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.
Time frame: Baseline and 4 months
Waist circumference
Measured by measuring tape
Time frame: Baseline and 4 months
Body mass index
Calculated by height and weight
Time frame: Baseline and 4 months
Body fat composition
Measured by bioimpedance scale
Time frame: Baseline and 4 months
Severity of sleep apnoea
Measured by a Home-sleep test
Time frame: 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.
Time frame: 4 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — It has not been mentioned during the IRB application
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Hong Kong Metropolitan University