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

NCT ID: NCT00493948

Last Updated: 2009-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Heart Failure, Congestive Sleep Apnea Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ApneaLink

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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ResMed

Principal Investigators

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Rachel A Coxon, BE/MBiomedE

Role: STUDY_DIRECTOR

ResMed/The University of New South Wales

Klaus Schindhelm, PhD

Role: STUDY_DIRECTOR

ResMed/The University of New South Wales

Jodie Lattimore, PhD

Role: STUDY_DIRECTOR

Royal Prince Alfred Hospital, Sydney, Australia

Ian Wilcox, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital/The University of Sydney

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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X06- 0237

Identifier Type: -

Identifier Source: org_study_id

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