Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Trazodone + PAP therapy
  • Oxygen + PAP therapy

Treatment groups

200 Participants
are divided into 2 treatment groups