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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 120
- Primary Endpoint
- Change in apnea hypopnea index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcome assessor did not aware of which groups the patients belongs to.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in apnea hypopnea index
Time Frame: Baseline, 4 months
Apnea hypopnea index will be asssessed by sleep test. The apnea hypopnea index is the number of times of apnea or hypopnea during one night, divided by the hours of sleep. The higher the apnea hypopnea index, the more severe sleep apnea is.
Secondary Outcomes
- Change in body weight(Baseline, 4 months and 12 months)
- Change in body neck circumference(Baseline, 4 months and 12 months)
- Change in apnea hypopnea index(Baseline and 12 months)
- Change in Duration of <90% oxygen desaturation(Baseline, 4 months and 12 months)
- Change objective physical activity level(Baseline, 4 months and 12 months)
- Change in lower limb strength(Baseline, 4 months and 12 months)
- Change in flexibility(Baseline, 4 months and 12 months)
- Change in balance(Baseline, 4 months and 12 months)
- Change in daytime sleepiness(Baseline, 4 months and 12 months)
- Change in sleep quality(Baseline, 4 months and 12 months)
- Change in dietary habits(Baseline, 4 months and 12 months)
- Change in self-efficacy in CPAP use(Baseline, 4 months and 12 months)
- Change in body fat(Baseline, 4 months and 12 months)
- Change in functional outcomes of sleep(Baseline, 4 months and 12 months)
- Change in depressive symptoms(Baseline, 4 months and 12 months)
- Change in subjective happiness(Baseline, 4 months and 12 months)
- Change in waist circumference(Baseline, 4 months and 12 months)
- Change in hip circumference(Baseline, 4 months and 12 months)
- Change in subjective physical activity level(Baseline, 4 months and 12 months)
- Intervention credibility(4 months and 12 months)
- Change in exercise and dietary control self-efficacy(Baseline, 4 months and 12 months)
- Change in perceived support from family and peers(Baseline, 4 months and 12 months)
- Change in Hand grip strength(Baseline, 4 months and 12 months)
- Change in quality of life(Baseline, 4 months and 12 months)
- Change in anxiety symptoms(Baseline, 4 months and 12 months)
- Change in patient activation(Baseline, 4 months and 12 months)
Investigators
Dr. Agnes Yuen-Kwan Lai
Assistant Professor
The University of Hong Kong