The Effectiveness of Smartphone Application on the Serevity of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Smartphone Application with lifestyle modification Intervention

• Registration Number: NCT05127239
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

A two-year study design is formulated. The overall aim of this study is to examine the effectiveness of the care model combing smartphone application on improve obstructive apnea in obesity adults.

Detailed Description

This study was the second year.The purpose of this study is to evaluate the effectiveness of the lifestyle modification intervention for overweight employees with obstructive sleep apnea. A randomized control trial with single blind will be used. Stratified with proportional randomized sampling will be employed and 160 suitable participants will be recruited from 4 electronics industries in northern of Taiwan. The subjects will be randomly divided into three groups. The total duration of intervention program is 6 months. Only the intervention group received the Combining Smartphone Application with lifestyle modification Intervention. The home portable sleep monitor will be used to collect the change of AHI at baseline, 3, and 6 months after intervention.

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2021-01-29
• Study Completion: 2021-10-08
• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Last Update Submitted: 2021-11-09
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

a) >21 years old; b) )BMI greater than24 kg/m2; (c) the absence of any mental disorder, alcohol and drug addiction, and serious disease, such as cancer or cardiorespiratory failure; and d) Screening for OSA , AHI>5 and voluntary participation.

Exclusion Criteria

• a) diagnosis of OSA and currently under treatment and；b) diagnosis of severe depression (c) have cardiopulmonary diseases and are not suitable for activities; and d) plan to become pregnant during or within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
smartphone application with education	Smartphone Application with lifestyle modification Intervention	participants were provides 3 times lifestyle modification education and using smartphone app program
smartphone application	Smartphone Application with lifestyle modification Intervention	participants were only provided smartphone app program

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	one night	using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index

Trial Locations

Locations (1)

Phison Electronics Corp; 🇨🇳 Miaoli, Taiwan