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Sponsored by: |
Nagasaki University |
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Information provided by: | Nagasaki University |
ClinicalTrials.gov Identifier: | NCT00503945 |
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 |
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Sleep Apnea |
Device: Nasal continuous positive airway pressure (nCPAP) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Clinical Significance of an Index of Cardiac Function, Tei-Index, in Obstructive Sleep Apnea Syndrome Patients. |
Enrollment: | 27 |
Study Start Date: | November 2004 |
Study Completion Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Second Department of Internal Medicine, Nagasaki University School of Medicine | |
Nagasaki, Japan, 852-8501 |
Study Chair: | Satoshi Ikeda, M.D., Ph.D. | Second Department of Internal Medicine, Nagasaki University School of Medicine |
Study ID Numbers: | Nagasaki-SAS |
Study First Received: | July 18, 2007 |
Last Updated: | July 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00503945 History of Changes |
Health Authority: | Japan: Institutional Review Board |
sleep apnea continuous positive airway pressure echocardiography Natriuretic peptide |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |