Lifestyle Modification Using an App in OSA

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189940
• Other study ID #: B-1504-296-302
• Status: Completed
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 13, 2017
• Start date: June 20, 2016
• Est. completion date: November 18, 2016

Study information

• Verified date: June 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 18, 2016
• Est. primary completion date: July 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

? patients must agree to participate in our clinical study ? patients without severe cardiopulmonary disease ? patients must be with BMI > 23 Kg/m2

Exclusion Criteria:

? patients who did not agree ? patients with severe cardiopulmonary disease ?patients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ? patients who were pregnant

Related Conditions & MeSH terms

• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Life 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.
• Conventional Life style modification
Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in body weight	body weight measurement and calculate into body mass index (BMI)	base line and after 4weeks of life style modiciation
Secondary	apnea hypopnea index (AHI)	number of apnea and or hypopnea event per hour during sleep	base line and after 4weeks of life style modiciation
Secondary	respiratory distress index (RDI)	AHI + number of respiratory effor related arousal (RERA) per hour during sleep	base line and after 4weeks of life style modiciation
Secondary	oxygen desaturation index (ODI)	number of desaturation event (peripheral oxygen satuation less than 90%) per hour during sleep	base line and after 4weeks of life style modiciation
Secondary	sleep time proportion with snoring loudness > 45dB	total duration of the snoring loudness >45 dB devided by the total sleep time (%)	base line and after 4weeks of life style modiciation
Secondary	lowest oxygen saturation	the degree of the lowest oxygen saturation measured during sleep	base line and after 4weeks of life style modiciation