ApneaLink in Sleep Apnea Syndromes and Heart Failure, Congestive - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: ApneaLink

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population under investigation is moderate to severe heart failure who are outpatients of a major Sydney hospital.

Description

Inclusion Criteria:

Moderate to severe Heart Failure (as determined by Echocardiogram or by treating physician)

Exclusion Criteria:

Malignant disease affecting gas exchange or respiratory parameters
Medications compromising breathing with no adverse affects on heart failure
Clinically significant (moderate to severe) asthma requiring therapy
Chronic parenchymal lung disease (FEV1/FVC ratio = 65% or as determined by the treating physician)
Severe pulmonary hypertension
Heart failure due to alcohol abuse or chemotherapy
Narcotic abuse/intravenous drug use (including HIV+ and hepatitis C)
Alcohol consumption > 80g/day
Patients receiving home Oxygen
Methicillin- resistant Staphylococcus aureus infection
Narcolepsy
Cataplexy
Enrolled in any concurrent study, that may confound the results of this study.
Inability or refusal to sign the Patient Consent Form
Inability or refusal to adhere to protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

Study Director: Rachel A Coxon, BE/MBiomedE, ResMed/The University of New South Wales
Study Director: Klaus Schindhelm, PhD, ResMed/The University of New South Wales
Study Director: Jodie Lattimore, PhD, Royal Prince Alfred Hospital, Sydney, Australia
Principal Investigator: Ian Wilcox, PhD, Royal Prince Alfred Hospital/The University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria