Lifestyle Modification Using an App in OSA

June 13, 2017 updated by: Jeong-Whun Kim, Seoul National University Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: App user group
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.
Sham Comparator: Control group
Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls
Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in body weight
Time Frame: base line and after 4weeks of life style modiciation
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)
Time Frame: base line and after 4weeks of life style modiciation
number of apnea and or hypopnea event per hour during sleep
base line and after 4weeks of life style modiciation
respiratory distress index (RDI)
Time Frame: base line and after 4weeks of life style modiciation
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)
Time Frame: base line and after 4weeks of life style modiciation
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
Time Frame: base line and after 4weeks of life style modiciation
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
Time Frame: base line and after 4weeks of life style modiciation
the degree of the lowest oxygen saturation measured during sleep
base line and after 4weeks of life style modiciation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jeong-Whun Kim, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2016

Primary Completion (Actual)

July 26, 2016

Study Completion (Actual)

November 18, 2016

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the individual data is confidential according to the hospital's policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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