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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 13, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07210606). This is a study registration, not published results. Lead sponsor: VA Office of Research and Development. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Sleep Disordered Breathing, Able Bodied. Interventions: DRUG: Trazodone + positive airway pressure (PAP) therapy; DRUG: Oxygen + positive airway pressure (PAP) therapy. Primary outcome measures: Carbon dioxide (CO2) Reserve , 120 days. Brief summary: 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.