Clinical trial NCT00503945: Cardiac Dysfunction in Obstructive Sleep Apnea Patients: Prevalence of and Effect of nCPAP
Official title: The Clinical Significance of an Index of Cardiac Function, Tei-Index, in Obstructive Sleep Apnea Syndrome Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea
continuous positive airway pressure
echocardiography
Natriuretic peptide
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: 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.
timeFrame: baseline, 1 month, 3months
Secondary outcomes:
measure: Effect of nCPAP treatment on plasma brain natriuretic peptide (BNP) level.
timeFrame: baseline, 1 month, 3 months
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Second Department of Internal Medicine, Nagasaki University School of Medicine
Study officials:
affiliation: Second Department of Internal Medicine, Nagasaki University School of Medicine
name: Satoshi Ikeda, M.D., Ph.D.
role: STUDY_CHAIR
References: