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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Smartphone Application with lifestyle modification Intervention
Sponsored by
Chang Gung University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, home portable sleep monitor, smartphone application, lifestyle modification intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Phison Electronics Corp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

smartphone application with education

smartphone application

waiting list

Arm Description

participants were provides 3 times lifestyle modification education and using smartphone app program

participants were only provided smartphone app program

No intervention was provided, but researchers explained the results of OSA screening for participants after every examination

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
November 9, 2021
Sponsor
Chang Gung University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05127239
Brief Title
The Effectiveness of Smartphone Application on the Serevity of Obstructive Sleep Apnea
Official Title
Constructing a Care Model Combing Smartphone Application to Improve Obstructive Apnea in Obesity Adults: a Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, home portable sleep monitor, smartphone application, lifestyle modification intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
The research assistant who assisted in the production of serial numbers was not involved in recruitment, intervention, or data collection. In addition, the researcher who performed the data analysis did not participate in recruitment, intervention or data collection.
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
smartphone application with education
Arm Type
Experimental
Arm Description
participants were provides 3 times lifestyle modification education and using smartphone app program
Arm Title
smartphone application
Arm Type
Experimental
Arm Description
participants were only provided smartphone app program
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
No intervention was provided, but researchers explained the results of OSA screening for participants after every examination
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Application with lifestyle modification Intervention
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index
Time Frame
one night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Chin Hsu, e-mail
Organizational Affiliation
Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phison Electronics Corp
City
Miaoli
ZIP/Postal Code
350
Country
Taiwan

12. IPD Sharing Statement

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

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