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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00493948

Enrollment

Registered

2007-06-29

Start date

2007-07-31

Completion date

2009-04-30

Last updated

2009-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive, Sleep Apnea Syndromes

Brief summary

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

Interventions

DEVICEApneaLink

A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Apnea- Hypopnea Index	Overnight

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026