Back to resultsLifestyle Modification Using an App in OSA
Primary Purpose
Obstructive Sleep Apnea, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Life style modification by using and app with a wrist-worn activity tracker
Conventional Life style modification
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
App user group
Control group
Arm Description
Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls
Outcomes
Primary Outcome Measures
changes in body weight
body weight measurement and calculate into body mass index (BMI)
Secondary Outcome Measures
apnea hypopnea index (AHI)
number of apnea and or hypopnea event per hour during sleep
respiratory distress index (RDI)
AHI + number of respiratory effor related arousal (RERA) per hour during sleep
oxygen desaturation index (ODI)
number of desaturation event (peripheral oxygen satuation less than 90%) per hour during sleep
sleep time proportion with snoring loudness > 45dB
total duration of the snoring loudness >45 dB devided by the total sleep time (%)
lowest oxygen saturation
the degree of the lowest oxygen saturation measured during sleep
Full Information
NCT ID
NCT03189940
First Posted
June 12, 2017
Last Updated
June 13, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03189940
Brief Title
Lifestyle Modification Using an App in OSA
Official Title
Effect of Lifestyle Modification Using Smartphone Application on Weight Reduction and Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
November 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
App user group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls
Intervention Type
Behavioral
Intervention Name(s)
Life style modification by using and app with a wrist-worn activity tracker
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Life style modification
Intervention Description
Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment
Primary Outcome Measure Information:
Title
changes in body weight
Description
body weight measurement and calculate into body mass index (BMI)
Time Frame
base line and after 4weeks of life style modiciation
Secondary Outcome Measure Information:
Title
apnea hypopnea index (AHI)
Description
number of apnea and or hypopnea event per hour during sleep
Time Frame
base line and after 4weeks of life style modiciation
Title
respiratory distress index (RDI)
Description
AHI + number of respiratory effor related arousal (RERA) per hour during sleep
Time Frame
base line and after 4weeks of life style modiciation
Title
oxygen desaturation index (ODI)
Description
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
Title
sleep time proportion with snoring loudness > 45dB
Description
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
Title
lowest oxygen saturation
Description
the degree of the lowest oxygen saturation measured during sleep
Time Frame
base line and after 4weeks of life style modiciation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Whun Kim, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the individual data is confidential according to the hospital's policy
Learn more about this trial
Lifestyle Modification Using an App in OSA
We'll reach out to this number within 24 hrs