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CompletedNCT03189940Updated Jun 16, 2017

Lifestyle Modification Using an App in OSA

An interventional study of Life style modification by using and app with a wrist-worn activity tracker and Conventional Life style modification in Obstructive Sleep Apnea and Obesity, sponsored by Seoul National University Hospital. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-16.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2016, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Obesity
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.

This study's enrollment of 59 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    App user group

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

  • 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

    Behavioral: Conventional Life style modification

Interventions

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

    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.

  • BehavioralConventional Life style modification

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

06

What researchers measure

Primary outcomes

  1. changes in body weight

    body weight measurement and calculate into body mass index (BMI)

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

Secondary outcomes

  1. apnea hypopnea index (AHI)

    number of apnea and or hypopnea event per hour during sleep

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

  2. respiratory distress index (RDI)

    AHI + number of respiratory effor related arousal (RERA) per hour during sleep

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

  3. oxygen desaturation index (ODI)

    number of desaturation event (peripheral oxygen satuation less than 90%) per hour during sleep

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

  4. sleep time proportion with snoring loudness > 45dB

    total duration of the snoring loudness \>45 dB devided by the total sleep time (%)

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

  5. lowest oxygen saturation

    the degree of the lowest oxygen saturation measured during sleep

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — the individual data is confidential according to the hospital's policy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03189940
Lead sponsor
Seoul National University Hospital
Responsible party
Jeong-Whun Kim (Clinical Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 16, 2017
Start date
Jun 20, 2016
Primary completion
Jul 26, 2016
Completion
Nov 18, 2016
Last update
Jun 16, 2017

Study contacts

Jeong-Whun Kim, MD, PhD
study director · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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