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

This study has been completed.
Sponsor:
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT00493948
First received: June 28, 2007
Last updated: November 9, 2009
Last verified: November 2009
History of Changes

June 28, 2007
November 9, 2009
July 2007
April 2009   (final data collection date for primary outcome measure)
Apnea- Hypopnea Index [ Time Frame: Overnight ] [ Designated as safety issue: No ]
Apnea- Hypopnea Index [ Time Frame: Overnight ]
Complete list of historical versions of study NCT00493948 on ClinicalTrials.gov Archive Site
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Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
  • Heart Failure, Congestive
  • Sleep Apnea Syndromes
Device: ApneaLink
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00493948
X06- 0237
No
Rachel Coxon, ResMed
ResMed
Not Provided
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
ResMed
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP