Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients with Heart Failure with Reduced or Mildly Reduced Left Ventricular Ejection Fraction (COG01)

February 6, 2025 updated by: Zoll Medical Corporation
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

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wrocław, Poland
        • Szpital Uniwersytecki we Wrocławiu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients 50 years or older with HFrEF/HFmrEF and no history of sleep disordered breathing (SDB) and not tested for SDB within the prior year will be tested for sleep apnea using a home sleep apnea test (WatchPAT device).

Description

Prevalence Phase Inclusion Criteria:

  1. Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF <50%) at least 3 months prior to enrollment
  2. New York Heart Association (NYHA) functional class II-IV
  3. 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
  4. Age 50 years or older
  5. Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
  6. 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:

  1. Hospitalized for heart failure-related complications in the last 4 weeks
  2. History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year

Cognitive Phase Inclusion Criteria:

  1. 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
  2. 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:

  1. Color blindness
  2. Currently taking opioids
  3. Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
  4. Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case group - subjects with central sleep apnea
Patients with moderate to severe CSA defined by an apnea hypopnea index (AHI) ≥ 15 events per hour and a central apnea hypopnea index (CAHI) ≥ 50% of total AHI.
Control group - subjects with no sleep disordered breathing
Patients with no SDB defined by an AHI < 5 events per hour.
Other SDB group - subjects with other forms of sleep disordered breathing
Patients that do not meet criteria for CSA or no SDB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of CSA in tested HFrEF/HFmrEF patients
Time Frame: Through study completion, an average of 1 year
Determine the prevalence of CSA in a contemporary population of HFrEF/HFmrEF patients completing a Home Sleep Apnea Test (using a WatchPAT device) during the prevalence phase of the study.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment.
Time Frame: Through study completion, an average of 1 year
Evaluate differences in cognitive function between adult patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (HFrEF/HFmrEF) (LVEF <50%) and central sleep apnea (CSA) versus patients with HFrEF/HFmrEF and no sleep disordered breathing (SDB) using a battery of assessments from the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

Investigators

  • Study Director: Kathy McPherson, ZOLL Respciardia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP3125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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