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

NCT ID: NCT00503945

Last Updated: 2007-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nasal continuous positive airway pressure (nCPAP)

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagasaki University

OTHER

Sponsor Role lead

Principal Investigators

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Satoshi Ikeda, M.D., Ph.D.

Role: STUDY_CHAIR

Second Department of Internal Medicine, Nagasaki University School of Medicine

Locations

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Second Department of Internal Medicine, Nagasaki University School of Medicine

Nagasaki, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Nagasaki-SAS

Identifier Type: -

Identifier Source: org_study_id