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

July 18, 2007 updated by: Nagasaki University

The Clinical Significance of an Index of Cardiac Function, Tei-Index, in Obstructive Sleep Apnea Syndrome Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Second Department of Internal Medicine, Nagasaki University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of nCPAP treatment on echocardiographic parameters including LVEF, left ventricular mass, ratio of E to A (E/A) and mitral deceleration time (DT) from the mitral inflow velocity, and Tei-index.
Time Frame: baseline, 1 month, 3months
baseline, 1 month, 3months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of nCPAP treatment on plasma brain natriuretic peptide (BNP) level.
Time Frame: baseline, 1 month, 3 months
baseline, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagasaki University

Investigators

  • Study Chair: Satoshi Ikeda, M.D., Ph.D., Second Department of Internal Medicine, Nagasaki University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (ESTIMATE)

July 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2007

Last Update Submitted That Met QC Criteria

July 18, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nagasaki-SAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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