Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

This study is currently recruiting participants.

Verified by ResMed, May 2008

Sponsored by:	ResMed
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00493948

Purpose

The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.

Condition	Intervention
Heart Failure, Congestive Sleep Apnea Syndromes	Device: ApneaLink

MedlinePlus related topics: Heart Failure Sleep Apnea

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

Further study details as provided by ResMed:

Primary Outcome Measures:

Apnea- Hypopnea Index [ Time Frame: Overnight ] [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2008

Intervention Details:

A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population under investigation are those people with moderate to severe heart failure who are currently admitted to the Coronary Care Unit of a major Sydney hospital.

Criteria

Inclusion Criteria:

Moderate to severe heart failure (as determined via Echocardiogram or treating physician)

Exclusion Criteria:

Clinically significant asthma requiring therapy
Significant (parenchymal) lung disease
Severe pulmonary hypertension
Hypercapnia (PCO2 > 60mmHg)
Cardiogenic Shock
Severe chronic renal failure
Narcotic abuse/intravenous drug use (including heart failure due to alcohol abuse or chemotherapy, HIV+ and Hepatitis C)
Methicillin- resistant Staphylococcus aureus infection
Tracheotomy
Enrolled in any concurrent study that may confound the results of this study
Nocturnal positive airway pressure or oxygen
Inability or refusal to sign patient consent form
Inability or refusal to adhere to protocol requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493948

Contacts

Contact: Rachel A Coxon, BE/MBiomedE

+64 02 88842328

rachelc@resmed.com.au

Locations

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

Sponsors and Collaborators

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

More Information

Responsible Party:	ResMed ( Rachel Coxon )
Study ID Numbers:	X06- 0237
Study First Received:	June 28, 2007
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00493948
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Heart Failure
Sleep Apnea Syndromes
Heart Diseases
Respiratory Tract Diseases
Apnea

Respiration Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009