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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor did not aware of which groups the patients belongs to.

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

The experimental group will receive usual care and Smart Sleep Apnea Self-management Support Programme (4S). The 4S includes two interview sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to self-management. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

General Hygiene Information (GH)

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

Group Type PLACEBO_COMPARATOR

General Hygiene Information (GH)

Intervention Type BEHAVIORAL

The control group will receive usual care and general hygiene information (GH). The GH includes two GH sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to general hygiene information. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

Interventions

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

The experimental group will receive usual care and Smart Sleep Apnea Self-management Support Programme (4S). The 4S includes two interview sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to self-management. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

Intervention Type BEHAVIORAL

General Hygiene Information (GH)

The control group will receive usual care and general hygiene information (GH). The GH includes two GH sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to general hygiene information. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

Intervention Type BEHAVIORAL

Other Intervention Names

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4S group GH group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No