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Completed

NCT Number: NCT05127239

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phison Electronics Corp

Miaoli, 350, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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

Treatment and study plan

Smartphone Application with lifestyle modification Intervention

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 .

Primary outcomes

  1. Apnea-Hypopnea Index

    Time frame: one night

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

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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