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OpenTrials
Completed

NCT Number: NCT03189940

Lifestyle Modification Using an App in OSA

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life style modification by using and app with a wrist-worn activity tracker

Behavioral

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.

Conventional Life style modification

Behavioral

Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 (%)

  5. lowest oxygen saturation

    Time frame: base line and after 4weeks of life style modiciation

    the degree of the lowest oxygen saturation measured during sleep

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2017
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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