NCT05127239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 9, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

Obstructive Sleep Apneahome portable sleep monitorsmartphone applicationlifestyle modification intervention

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index

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

    one night

Study Arms (3)

smartphone application with education

EXPERIMENTAL

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

Behavioral: Smartphone Application with lifestyle modification Intervention

smartphone application

EXPERIMENTAL

participants were only provided smartphone app program

Behavioral: Smartphone Application with lifestyle modification Intervention

waiting list

NO INTERVENTION

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

Interventions

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 applicationsmartphone application with education

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phison Electronics Corp

Miaoli, 350, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Hsiu-Chin Hsu, e-mail

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

October 15, 2020

Primary Completion

January 29, 2021

Study Completion

October 8, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations