A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: General Hygiene Information (GH); Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)

Study type: Interventional

Funder types: Other

Identifiers

NCT05390138

UW 21-135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Smart Sleep Apnea Self-management Support Programme (4S)

Experimental group

Description:

Patients will receive Smart Sleep Apnea Self-management Support Programme (4S) in addition to usual care

Treatment:

Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)

General Hygiene Information (GH)

Placebo Comparator group

Description:

Patients will receive general hygiene information (GH) in addition to usual care

Treatment:

Behavioral: General Hygiene Information (GH)