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

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Nasal continuous positive airway pressure (nCPAP)

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, continuous positive airway pressure, echocardiography, Natriuretic peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Second Department of Internal Medicine, Nagasaki University School of Medicine

Outcomes

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.

Secondary Outcome Measures

Effect of nCPAP treatment on plasma brain natriuretic peptide (BNP) level.

Full Information

NCT ID

NCT00503945

First Posted

July 18, 2007

Last Updated

July 18, 2007

Sponsor

Nagasaki University

1. Study Identification

Unique Protocol Identification Number

NCT00503945

Brief Title

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

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nagasaki University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Nasal continuous positive airway pressure (nCPAP)

Primary Outcome Measure Information:

Title

Time Frame

baseline, 1 month, 3months

Secondary Outcome Measure Information:

Title

Effect of nCPAP treatment on plasma brain natriuretic peptide (BNP) level.

Time Frame

baseline, 1 month, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satoshi Ikeda, M.D., Ph.D.

Organizational Affiliation

Second Department of Internal Medicine, Nagasaki University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Second Department of Internal Medicine, Nagasaki University School of Medicine

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

12. IPD Sharing Statement

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

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