Lifestyle Modification Using an App in OSA

Not Applicable

Completed

• Conditions: Obesity; Obstructive Sleep Apnea
• Interventions: Behavioral: Life style modification by using and app with a wrist-worn activity tracker; Behavioral: Conventional Life style modification

• Registration Number: NCT03189940
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-20
• Primary Completion: 2016-07-26
• Study Completion: 2016-11-18
• Status Verified: 2017-06
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App user group	Life style modification by using and app with a wrist-worn activity tracker	-
Control group	Conventional Life style modification	Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls

Primary Outcome Measures

Name	Time	Method
changes in body weight	base line and after 4weeks of life style modiciation	body weight measurement and calculate into body mass index (BMI)

Secondary Outcome Measures

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