NCT06313840

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function

Detailed description

The study will be conducted in two phases: prevalence phase and cognitive phase. Adult patients with HFrEF/HFmrEF will perform a home sleep apnea test (HSAT). Patients will be assigned to one of the following groups based on their sleep study results: CSA, other SDB, or no SDB. This constitutes the prevalence phase of the study. The cognitive phase of the study is a case-control study that will assess cognitive function in 20 patients in the CSA group (case) and 20 patients in the no SDB group (control).

Conditions

• Heart Failure
• Central Sleep Apnea

Timeline

• Start date: 2023-08-21
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2024-03-15
• Last updated: 2025-02-10

Locations

1 site across 1 country: Poland