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

9. november 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

146

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: smartphone application with education
participants were provides 3 times lifestyle modification education and using smartphone app program
Adfærdsmæssigt: 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 .
Eksperimentel: smartphone application
participants were only provided smartphone app program
Adfærdsmæssigt: 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 .
Ingen indgriben: waiting list
No intervention was provided, but researchers explained the results of OSA screening for participants after every examination

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Apnea-Hypopnea Index
Tidsramme: one night
using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index
one night

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chang Gung University of Science and Technology

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2020

Primær færdiggørelse (Faktiske)

29. januar 2021

Studieafslutning (Faktiske)

8. oktober 2021

Datoer for studieregistrering

Først indsendt

9. november 2021

Først indsendt, der opfyldte QC-kriterier

9. november 2021

Først opslået (Faktiske)

19. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201802318B0A3

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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