Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
ResMed Identifier:
First received: June 28, 2007
Last updated: November 9, 2009
Last verified: November 2009
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:

Further study details as provided by ResMed:

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

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.

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00493948

Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
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

Responsible Party: Rachel Coxon, ResMed Identifier: NCT00493948     History of Changes
Other Study ID Numbers: X06- 0237
Study First Received: June 28, 2007
Last Updated: November 9, 2009

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes processed this record on May 25, 2017