- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189940
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
Status
Completed
Conditions
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1504-296-302
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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