NCT00503945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
Last Updated

July 19, 2007

Status Verified

July 1, 2007

First QC Date

July 18, 2007

Last Update Submit

July 18, 2007

Conditions

Sleep Apnea

Keywords

sleep apneacontinuous positive airway pressureechocardiographyNatriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    baseline, 1 month, 3 months

Interventions

Nasal continuous positive airway pressure (nCPAP)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSAS patients: Moderate to severe OSAS patients with apnea-hypopnea index (AHI) ≥ 20 events/hour by overnight polysomnography and start nCPAP treatment.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Internal Medicine, Nagasaki University School of Medicine

Nagasaki, 852-8501, Japan

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Satoshi Ikeda, M.D., Ph.D.

    Second Department of Internal Medicine, Nagasaki University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 19, 2007

Study Start

November 1, 2004

Study Completion

November 1, 2006

Last Updated

July 19, 2007

Record last verified: 2007-07

Locations

JP(1)