Lifestyle Modification Using an App in OSA

Study Overview
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Brief Summary
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This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged > 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.

Official Title
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Effect of Lifestyle Modification Using Smartphone Application on Weight Reduction and Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea, Obesity

Intervention / Treatment
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* Behavioral: Life style modification by using and app with a wrist-worn activity tracker
* Behavioral: Conventional Life style modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI > 23 Kg/m2 Exclusion Criteria: ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: App user group<br> | Behavioral: Life style modification by using and app with a wrist-worn activity tracker<br>* The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data.<br>|
| Sham Comparator: Control group<br>Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls | Behavioral: Conventional Life style modification<br>* Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in body weight | body weight measurement and calculate into body mass index (BMI) | base line and after 4weeks of life style modiciation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea hypopnea index (AHI) | number of apnea and or hypopnea event per hour during sleep | base line and after 4weeks of life style modiciation | 
| respiratory distress index (RDI) | AHI + number of respiratory effor related arousal (RERA) per hour during sleep | base line and after 4weeks of life style modiciation | 
| oxygen desaturation index (ODI) | number of desaturation event (peripheral oxygen satuation less than 90%) per hour during sleep | base line and after 4weeks of life style modiciation | 
| sleep time proportion with snoring loudness > 45dB | total duration of the snoring loudness >45 dB devided by the total sleep time (%) | base line and after 4weeks of life style modiciation | 
| lowest oxygen saturation | the degree of the lowest oxygen saturation measured during sleep | base line and after 4weeks of life style modiciation |