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

November 9, 2021 updated by: Hsu Hsiu-Chin, Chang Gung University of Science and Technology

Constructing a Care Model Combing Smartphone Application to Improve Obstructive Apnea in Obesity Adults: a Longitudinal Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Miaoli, Taiwan, 350
        • Phison Electronics Corp

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: smartphone application with education
participants were provides 3 times lifestyle modification education and using smartphone app program
Behavioral: Smartphone Application with lifestyle modification Intervention
The study will introduce a health-promoting lifestyle through the combination of a smartphone app (MyFitnessPal) for the experimental group, emphasizing the use of behavior change techniques to reduce weight, thereby improving the obstructive sleep apnea with overweight and obese employees in the workplace. The self-monitoring, instant feedback, and social support, as well as individualized tailor-made functions are used in intervention programs. The intervention process adopts a healthy weight reduction plan, focusing on a balanced diet, moderately reducing the calories of the food, and combining weight loss methods such as increasing exercise as the main axis, emphasizing the concept of self-monitoring of weight, calorie intake, and exercise .
Experimental: smartphone application
participants were only provided smartphone app program
Behavioral: Smartphone Application with lifestyle modification Intervention
The study will introduce a health-promoting lifestyle through the combination of a smartphone app (MyFitnessPal) for the experimental group, emphasizing the use of behavior change techniques to reduce weight, thereby improving the obstructive sleep apnea with overweight and obese employees in the workplace. The self-monitoring, instant feedback, and social support, as well as individualized tailor-made functions are used in intervention programs. The intervention process adopts a healthy weight reduction plan, focusing on a balanced diet, moderately reducing the calories of the food, and combining weight loss methods such as increasing exercise as the main axis, emphasizing the concept of self-monitoring of weight, calorie intake, and exercise .
No Intervention: waiting list
No intervention was provided, but researchers explained the results of OSA screening for participants after every examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index
Time Frame: one night
using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index
one night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University of Science and Technology

Investigators

  • Principal Investigator: Hsiu-Chin Hsu, e-mail, Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology

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)

October 15, 2020

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

October 8, 2021

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201802318B0A3

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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