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

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ClinicalTrials.gov Identifier: NCT00493948
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
ResMed

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

Condition or disease Intervention/treatment
Heart Failure, Congestive Sleep Apnea Syndromes Device: ApneaLink

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
Study Start Date : July 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Device: ApneaLink
    A two channel sleep screening device for the assessment of Sleep Disordered Breathing.


Primary Outcome Measures :
  1. Apnea- Hypopnea Index [ Time Frame: Overnight ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493948


Locations
Australia, New South Wales
Royal Prince Alfred Hospital
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

Responsible Party: Rachel Coxon, ResMed
ClinicalTrials.gov Identifier: NCT00493948     History of Changes
Other Study ID Numbers: X06- 0237
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes