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

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ResMed

Status

Completed

Conditions

Sleep Apnea Syndromes
Heart Failure, Congestive

Treatments

Device: ApneaLink

Study type

Observational

Funder types

Industry

Identifiers

NCT00493948
X06- 0237

Details and patient eligibility

About

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

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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