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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503945
• Other study ID #: Nagasaki-SAS
• Status: Completed
• Phase: N/A
• First received: July 18, 2007
• Last updated: July 18, 2007
• Start date: November 2004
• Est. completion date: November 2006

Study information

• Verified date: July 2007
• Source: Nagasaki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Nasal continuous positive airway pressure (nCPAP)

Locations

Country	Name	City	State
Japan	Second Department of Internal Medicine, Nagasaki University School of Medicine	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Nagasaki University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline, 1 month, 3months
Secondary	Effect of nCPAP treatment on plasma brain natriuretic peptide (BNP) level.		baseline, 1 month, 3 months