Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction

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• Prevalence Phase Inclusion Criteria:
• Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF <50%) at least 3 months prior to enrollment
• New York Heart Association (NYHA) functional class II-IV
• Treated and optimized on heart failure guideline directed medical therapy as indicated for at least 4 weeks, including angiotensin receptor-neprilysin inhibitors (ARNI) (or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)), aldosterone receptor antagonists, beta-blockers and/or sodium glucose co-transporter 2 (SGLT-2) antagonists
• Age 50 years or older
• Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
• In the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment
  • Prevalence Phase Exclusion Criteria:
• Hospitalized for heart failure-related complications in the last 4 weeks
• History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year
  • Cognitive Phase Inclusion Criteria:
• AHI ≥ 15 events per hour and CAHI ≥ 50% of total AHI (Case group) or AHI < 5 events per hour (Control group) based on the baseline HSAT
• Per the patient and investigator, willing and able to postpone CSA treatment until completion of the study assessment visit (Visit 3)
  • Cognitive Phase Exclusion Criteria:
• Color blindness
• Currently taking opioids
• Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
• Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
• Diagnosed with neurological disease including but not limited to history of seizures, meningitis, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, attention-deficit/hyperactivity disorder (ADHD) or autism.