Clinical trial NCT05390138: A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea
Official title: A Smart Sleep Apnea Self-management Support Programme(4S) to Improve Apnea Severity and Cardiovascular Health - A Pragmatic Randomized Controlled Trial With Mixed-method Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2-group randomisation controlled trial with 4-month and 12-month follow-up. The Experimental group will receive 4S intervention in relation to self-management and the Control group will receive general hygiene information.
Primary purpose: SUPPORTIVE_CARE

Brief summary: OSA is a chronic disease with high prevalence that parallels with increasing obesity. Self-management programmes are perceived to be cost-effective in long-term OSA patient care and can supplement regular medical treatments. The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group.

Detailed description: OSA is a chronic disease with high prevalence that parallels with increasing obesity. OSA affects around 12% and 24% of adults in Hong Kong and China Mainland, respectively. Chronic intermittent hypoxia and sleep fragmentation of OSA leads to cardiometabolic and neurocognitive sequelae (e.g. hypertension, diabetes, daytime sleepiness and depression). Long-term, multidisciplinary management involving patients in decision-making of treatment strategies, shifting from positive airway pressure (PAP) device-focused to the patient-centered chronic care model has been suggested.

Mobile instant messaging (such as WhatsApp/WeChat) are popular and inexpensive for interactive messaging. Smartphone-based self-management interventions were reported improved self-efficacy and clinical outcomes in patients with chronic diseases. The investigator only found one mobile health application to support CPAP therapy for OSA and one ongoing trial of OSA self-management telematic support to improve CPAP adherence. There is underutilization of mobile technology in patient-centered self-management programmes to improve PAP treatment and lifestyle modifications in OSA.

The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group. Questionnaire and simple fitness assessment will be used to assess the effectivness of the intervention at 4-month and 12-month follow-up. Focus group interview will be conducted to collect qualiatative feedback on the intervention.

Eligibility criteria: Inclusion Criteria:

* aged 18 years and above;
* diagnosis of moderate to severe obstructive sleep apnea (AHI≥15);
* 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 and read Chinese;
* willing to complete the questionnaires and assessments;
* has a smartphone with instant messaging function (eg. WhatsApp/WeChat); and
* willing to give informed consent.

Exclusion Criteria:

* sleep disorder other than OSA;
* clinically significant psychiatric, neurological, or medical disorder other than OSA; and
* use of prescription drugs or clinically significant drugs affecting sleep.

Primary outcomes:
measure: Change in apnea hypopnea index
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in apnea hypopnea index
timeFrame: Baseline and 12 months
measure: Change in Duration of <90% oxygen desaturation
timeFrame: Baseline, 4 months and 12 months
measure: Change in body weight
timeFrame: Baseline, 4 months and 12 months
measure: Change in body fat
timeFrame: Baseline, 4 months and 12 months
measure: Change in body neck circumference
timeFrame: Baseline, 4 months and 12 months
measure: Change in waist circumference
timeFrame: Baseline, 4 months and 12 months
measure: Change in hip circumference
timeFrame: Baseline, 4 months and 12 months
measure: Change objective physical activity level
timeFrame: Baseline, 4 months and 12 months
measure: Change in Hand grip strength
timeFrame: Baseline, 4 months and 12 months
measure: Change in lower limb strength
timeFrame: Baseline, 4 months and 12 months
measure: Change in flexibility
timeFrame: Baseline, 4 months and 12 months
measure: Change in balance
timeFrame: Baseline, 4 months and 12 months
measure: Change in daytime sleepiness
timeFrame: Baseline, 4 months and 12 months
measure: Change in sleep quality
timeFrame: Baseline, 4 months and 12 months
measure: Change in functional outcomes of sleep
timeFrame: Baseline, 4 months and 12 months
measure: Change in quality of life
timeFrame: Baseline, 4 months and 12 months
measure: Change in anxiety symptoms
timeFrame: Baseline, 4 months and 12 months
measure: Change in depressive symptoms
timeFrame: Baseline, 4 months and 12 months
measure: Change in subjective happiness
timeFrame: Baseline, 4 months and 12 months
measure: Change in subjective physical activity level
timeFrame: Baseline, 4 months and 12 months
measure: Change in dietary habits
timeFrame: Baseline, 4 months and 12 months
measure: Change in self-efficacy in CPAP use
timeFrame: Baseline, 4 months and 12 months
measure: Change in exercise and dietary control self-efficacy
timeFrame: Baseline, 4 months and 12 months
measure: Change in perceived support from family and peers
timeFrame: Baseline, 4 months and 12 months
measure: Change in patient activation
timeFrame: Baseline, 4 months and 12 months
measure: Intervention credibility
timeFrame: 4 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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