Personalised Active Self-management of Sleep Apnea Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4-month Personalized and Adaptive Sleep Support program (PASS), Control group.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 enga - 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
Primary outcome measures
- Positive airway pressure (PAP) therapy uptake [Time frame: Baseline and 4 months]
- Program feasibility and acceptability [Time frame: 4 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Hong Kong · 1 center
- Queen Mary Hopsital — Hong Kong
Identifiers
NCT: NCT07494292 · UW 25-460