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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 28, 2007

Last Updated Date

March 22, 2009

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00493948 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Heart Failure, Congestive
Sleep Apnea Syndromes

Intervention ^†

Device: ApneaLink

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

May 2009

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Rachel A Coxon, BE/MBiomedE

+64 02 88842328

rachelc@resmed.com.au

Location Countries ^†

Australia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00493948

Responsible Party

Rachel Coxon, ResMed

Secondary IDs ^††

Study Sponsor ^†

ResMed

Collaborators ^††

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

Information Provided By

ResMed

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.