Heart Failure, Sleep Apnea
Conditions
Keywords
Cheyne Stocks respiration, heart failure, sleep apnea, ventilator
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. 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 2. Subject is \> 18 years old 3. 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 4. Expected to tolerate the ventilator therapy
Exclusion criteria
1. Baseline oxygen saturation \< 90% on a stable FIO2) 2. Patient is currently enrolled in another clinical study which may confound the results of this study 3. Patient for whom informed consent cannot be obtained 4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure 5. 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) 6. Patients with severe COPD (per GOLD scale) 7. Patients with a history of myocardial infarction within the 6 months prior to the study 8. Patients with unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Both ASV and Bilevel ventilation are effective in clinical treatment of CSR | three months |
Secondary
| Measure | 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 |
Countries
China