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Cardiac Dysfunction in Obstructive Sleep Apnea Patients: Prevalence of and Effect of nCPAP

N

Nagasaki University

Status

Completed

Conditions

Sleep Apnea

Treatments

Device: Nasal continuous positive airway pressure (nCPAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT00503945
Nagasaki-SAS

Details and patient eligibility

About

The aim of this study is to clarify the influence of obstructive sleep apnea syndrome on left ventricular function using echocardiographic parameters including the myocardial performance index (Tei-index), and to determine the short-term effects of nCPAP on them.

Full description

Obstructive sleep apnea syndrome (OSAS) affects 2% and 4% of middle-aged women and men respectively, and is associated with an increased risk of cardiovascular complications. Therefore, cardiovascular consequences must be evaluated in the clinical management of OSAS and the study of cardiac functional parameters could be particularly useful. Reported findings are conflicting with respect to the influence of OSAS and nasal continuous positive airway pressure (nCPAP) on left ventricular function. In this study, we assess cardiac dysfunction with echocardiographic parameters, such as LVEF, left ventricular mass, ratio of E to A (E/A) and mitral deceleration time (DT) from the mitral inflow velocity, and Tei-index, or plasma brain natriuretic peptide (BNP) level at baseline, and 1 and 3 months after nCPAP treatment. The main endpoint is the comparison of echocardiographic parameters and BNP between OSAS patients and control subjects, and the changes of them after short-term of nCPAP treatment.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • OSAS patients: Moderate to severe OSAS patients with apnea-hypopnea index (AHI) ≥ 20 events/hour by overnight polysomnography and start nCPAP treatment.

Exclusion criteria

  • Apparent lung diseases
  • Daytime hypoxemia (PaO2 <80 mmHg)
  • Atrial fibrillation, bundle branch block, atrioventricular block and implantable pacemaker
  • Left ventricular dysfunction (ejection fraction <50%)
  • Ischemic or valvular heart disease, and cardiomyopathy determined from medical history or a physical examination, electrocardiogram (ECG), chest radiography, and echocardiography
  • Renal insufficiency (serum creatinine >2.0 mg/dl).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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