Central Sleep Apnea in Heart Failure: How Mechanisms May Guide Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates mechanistic pathways underlying central sleep apnea in people with heart failure and reduced ejection fraction. It uses a multi-modality approach, pairing PAP therapy to keep airways open with pharmacologic or supplemental oxygen strategies to address the brain’s breathing control. Specific aims assess whether lowering respiratory arousals and reducing peripheral chemoreceptor sensitivity widen the CO2 reserve and decrease CSA indices. The setting involves Veterans, with stable heart failure management, at the John D. Dingell VA Medical Center. Results could inform future multi-modality treatment strategies for CSA in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Pregnant or breastfeeding females
* Moderate or severe obstructive or restrictive lung disease, including supplemental oxygen (O2) use
* Current treatment for central sleep apnea (CSA), including any form of positive airway pressure (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)
* Positive airway pressure (PAP)-emergent central sleep apnea
* Lack of positive airway pressure (PAP) acceptance/adherence after a one-week home PAP trial after enrollment

Additional Trazodone Exclusions:

* Prolonged QT on baseline electrocardiogram (ECG), using medications that inhibit CYP3A4
* Patients with severe renal impairment (glomerular filtration rate (GFR) \< 20 milliliters per minute/1.73 square meters) or end-stage renal disease

Where it's running

• John D. Dingell VA Medical Center, Detroit, MI
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: M Safwan Badr, MD — John D. Dingell VA Medical Center, Detroit, MI
• Study coordinator: M S Badr, MD
• Email: sbadr@med.wayne.edu
• Phone: (313) 576-1000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.