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The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity.

18. september 2021 opdateret af: Chung-Chieh, Yu, Chang Gung Memorial Hospital

The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity and Left Ventricle Mass in Obstructive Sleep Apnea-hypopnea Syndrome.

The ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA. This study investigate the effect of CPAP on ROCK activity and left ventricle mass.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

The ROCK were discovered as downstream targets of Ras homologous A and regulate various important cellular functions, including proliferation, migration, adhesion, and apoptosis. They play a critical role in the pathogenesis of cardiovascular diseases, including cardiac fibrosis, hypertrophy, and remodeling. ROCK activity can be detected in human circulating leukocytes and could potentially be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. It has been proven that higher ROCK activity is present in left ventricle hypertrophy (LVH) patients than those without LVH. Obstructive sleep apnea(OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep that leads to intermittent nocturnal hypoxia, resulting in a broad range of cardiovascular morbidities, including coronary artery disease, heart failure, cardiac arrhythmias, and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA and several studies have shown that it can effectively reduce cardiovascular disease, but the effect of CPAP on left ventricle mass reduction is still uncertain. Previous studies demonstrated that patients with OSA had higher circulatory ROCK activity than those without OSA, but the role of CPAP on ROCK activity is not known. The circulatory leukocyte ROCK activity may be used as a clinical biomarker for cardiovascular disease and ROCK inhibitors may be used in the future as a treatment. OSA and CPAP treatment may also affect ROCK activity, the relationship between CPAP treatment, cardiac hypertrophy, and ROCK activity is important and should be clarified. Therefore, the main purpose of our study is to evaluate the effect of CPAP on ROCK activity and left ventricle mass.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

160

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Keelung, Taiwan, 204
        • Rekruttering
        • Sleep center

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

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects who have snoring or any other symptoms of sleep breathing disorders receive a standard polysomnography study in the Chang Gung Sleep Center of Keelung.

Beskrivelse

Inclusion Criteria:

● Subjects who complete a standard polysomnography study.

Exclusion Criteria:

  • Patients who have heart failure (as determined by clinical symptoms or signs with elevated brain natriuretic peptide and echocardiography showing structural or functional abnormalities)
  • Coronary artery disease (stress electrocardiography, myocardial scintigraphy, or coronary angiography proven coronary artery lesion)
  • Hypertrophic cardiomyopathy
  • Known infiltrative disease e.g. amyloidosis
  • Chronic kidney disease severe than stage III
  • Ischemic or hemorrhagic stroke
  • Central sleep apnea,
  • Hypoventilation syndrome (TCO2 or artery PaCO2 exceed 50 mmHg)
  • Unstable hemodynamic state
  • Eastern Cooperative Oncology Group Performance Status higher than grade 2
  • Pregnant women will be excluded.
  • Polysomnography exam showing sleep time less than 2 hours
  • Patients who receive surgery or oral appliance during the study period

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Control group
Polysomography show AHI less than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months.
OSA without CPAP group
Polysomography show AHI greater than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months.
OSA with CPAP group
Polysomography show AHI greater than 15 events/h and participants receive CPAP more than 6 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ROCK activity
Tidsramme: Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
Compare the change of blood ROCK 1, ROCK 2, and MYTP-1 p/t (The levels of phosphorylated to total myosin light chain phosphatase 1) among those three groups.
Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
Left ventricle mass
Tidsramme: Do baseline echocardiography and follow up echocardiography in six months later.
Compare the change left ventricle mass index among those three groups.
Do baseline echocardiography and follow up echocardiography in six months later.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure
Tidsramme: Obtain initial and blood pressure six months later.
Compare the blood pressure among those three groups.
Obtain initial and blood pressure six months later.

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Forventet)

1. oktober 2021

Primær færdiggørelse (Forventet)

1. juni 2024

Studieafslutning (Forventet)

1. december 2024

Datoer for studieregistrering

Først indsendt

14. august 2021

Først indsendt, der opfyldte QC-kriterier

14. august 2021

Først opslået (Faktiske)

20. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

Requestors need application and explain the purpose. The data access will be provided after approved by review panel.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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