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

Completed

• Conditions: Heart Failure, Congestive; Sleep Apnea Syndromes

• Registration Number: NCT00493948
• Lead Sponsor: ResMed

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Study Start: 2007-07
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea- Hypopnea Index	Overnight

Trial Locations

Locations (1)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia