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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503945
First Posted: July 19, 2007
Last Update Posted: July 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nagasaki University
  Purpose
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.

Condition Intervention
Sleep Apnea Device: Nasal continuous positive airway pressure (nCPAP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Significance of an Index of Cardiac Function, Tei-Index, in Obstructive Sleep Apnea Syndrome Patients.

Resource links provided by NLM:


Further study details as provided by Nagasaki University:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 27
Study Start Date: November 2004
Study Completion Date: November 2006
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503945


Locations
Japan
Second Department of Internal Medicine, Nagasaki University School of Medicine
Nagasaki, Japan, 852-8501
Sponsors and Collaborators
Nagasaki University
Investigators
Study Chair: Satoshi Ikeda, M.D., Ph.D. Second Department of Internal Medicine, Nagasaki University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00503945     History of Changes
Other Study ID Numbers: Nagasaki-SAS
First Submitted: July 18, 2007
First Posted: July 19, 2007
Last Update Posted: July 19, 2007
Last Verified: July 2007

Keywords provided by Nagasaki University:
sleep apnea
continuous positive airway pressure
echocardiography
Natriuretic peptide

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases