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

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

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Key information

Conditions

Heart Failure, Congestive Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Heart Failure Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApneaLink

Device

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

Primary outcomes

Apnea- Hypopnea Index

Time frame: Overnight

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 29, 2007
Registry last updated: Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed