Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

This study is looking for Veterans with central sleep apnea (CSA) and heart failure to understand better ways to treat their condition. CSA is when you stop breathing during sleep because your brain doesn't send the right signals to your breathing muscles. The study will test if adding trazodone (a medication) or oxygen to positive airway pressure (PAP) therapy can improve CSA. PAP therapy is a common treatment that uses a machine to help you breathe. Researchers want to see if these combinations can help normalize breathing and reduce the long-term problems of CSA. To join, you must be a Veteran with central sleep apnea and stable heart failure. The main goal is to measure your CO2 Reserve (how much carbon dioxide your body can handle) after 120 days to see if the treatments are working. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 200 participants. It will compare different treatment combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your CO2 Reserve will be measured at 120 days to see the treatment's effect.

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NCT07210606

Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
VA Office of Research and Development
~200 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Trazodone + PAP therapyOxygen + PAP therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CO2 Reserve
Measured over 120 days
Sleep Disordered Breathing
Able Bodied
1 sites across 1 states
Michigan1
  • M Safwan Badr, MD · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center, Detroit, MI

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Eligibility criteria

Inclusion

Men and Women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included with the experiments.
Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations or change in the medical regimen for the past 90 days before enrollment.

Exclusion

less than 18 years old
pregnant or breastfeeding females
moderate or severe obstructive or restrictive lung disease, including supplemental o2 use
current treatment for CSA, including any form of PAP in the past three months, or phrenic nerve situation.
too ill to engage in the study procedures, inability to provide consent for participation.
a history of cardiac arrhythmia
Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program
depression or a history of suicidality
severe insomnia (ISI\>21) or reported short sleep duration (\<6 hours)
PAP-emergent central sleep apnea
Lack of PAP acceptance/adherence after a one-week home PAP trial after enrollment.
Prolonged QT on baseline ECG, using medications that inhibit CYP3A4
Patients with severe renal impairment (GFR \< 20ml/min/1.73m2) or end-stage renal disease
  • CO2 Reserve120 days

    CO2 reserve is the requisite change to induce central apnea to as the CO2 reserve, which can be positive or negative.