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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
  Purpose

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


Condition Intervention
Heart Failure, Congestive
Sleep Apnea Syndromes
 Device: ApneaLink

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Apnea- Hypopnea Index [ Time Frame: Overnight ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ApneaLink
    A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Rachel Coxon, ResMed
ClinicalTrials.gov Identifier: NCT00493948     History of Changes
Other Study ID Numbers: X06- 0237
Study First Received: June 28, 2007
Last Updated: November 9, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013