Health TrialsbyHealthPanel

Personalised Active Self-management of Sleep Apnea Program

ConditionObstructive Sleep Apnea (OSA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHong Kong Metropolitan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Clinically significant psychiatric disorder

Use of prescription drugs or clinically significant drugs affecting sleep.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: General Hygiene Control groupActive comparator 1 intervention
Group B: PASS Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Program feasibility and acceptability

Evaluated via semi-structured interviews

Time frame
4 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Metropolitan University

Lead sponsor

Queen Mary Hospital, Hong Kong

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: