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

NCT ID: NCT05127239

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-10-08

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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Obstructive Sleep Apnea home portable sleep monitor smartphone application lifestyle modification intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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smartphone application with education

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

Group Type EXPERIMENTAL

Smartphone Application with lifestyle modification Intervention

Intervention Type BEHAVIORAL

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 .

smartphone application

participants were only provided smartphone app program

Group Type EXPERIMENTAL

Smartphone Application with lifestyle modification Intervention

Intervention Type BEHAVIORAL

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 .

waiting list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Hsu Hsiu-Chin

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsiu-Chin Hsu, e-mail

Role: PRINCIPAL_INVESTIGATOR

Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology

Locations

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Phison Electronics Corp

Miaoli, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201802318B0A3

Identifier Type: -

Identifier Source: org_study_id