Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.

Conditions
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Heart Failure, Sleep Apnea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States Subject is > 18 years old Patients with known history of CSR. CSR symptoms may include the following: sleep fragmentation as reported by patient or as witnessed by another person night arousal after apneic episodes reduced exercise capacity daytime sleepiness Expected to tolerate the ventilator therapy Exclusion Criteria: Baseline oxygen saturation < 90% on a stable FIO2) Patient is currently enrolled in another clinical study which may confound the results of this study Patient for whom informed consent cannot be obtained Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency) Patients with severe COPD (per GOLD scale) Patients with a history of myocardial infarction within the 6 months prior to the study Patients with unstable angina

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E, 2, III<br>To treat CSR with ASV and Bilevel ventilators | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Both ASV and Bilevel ventilation are effective in clinical treatment of CSR |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cheyne Stocks respiration, heart failure, sleep apnea, ventilator