Heart FailureCOG01NCT06313840
Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction
An observational study of Heart Failure and Central Sleep Apnea, run by Zoll Medical Corporation at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Central Sleep Apnea
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 21 Aug 2023to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Medical subject headings
- Heart Failure, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CSA in tested HFrEF/HFmrEF patients
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment.
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 Aug 2023
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy McPherson, Study director, ZOLL Respciardia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313840
- Sponsor's protocol ID
- CIP3125
- Acronym
- COG01
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT06313840
- Acronym / sponsor ID
- COG01 / CIP3125
- Conditions
- Heart Failure, Central Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy McPherson study director
ZOLL Respciardia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Central Sleep Apnea, run by Zoll Medical Corporation at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CSA in tested HFrEF/HFmrEF patients (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.