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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503945

Enrollment

Registered

2007-07-19

Start date

2004-11-30

Completion date

2006-11-30

Last updated

2007-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

sleep apnea, continuous positive airway pressure, echocardiography, Natriuretic peptide

Brief 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.

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.

Interventions

DEVICENasal continuous positive airway pressure (nCPAP)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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.	baseline, 1 month, 3months

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026