NCT07210606RecruitingPhase 4
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 29 Sept 2025
- Start date
- 16 Sept 2026
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Heart failure
- NCT number
- NCT07210606
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 16 Sept 2026 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Moderate or severe obstructive or restrictive lung disease, including supplemental oxygen (O2) use
- A history of cardiac arrhythmia
- Depression or a history of suicidality
Lab values
- 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
Other
- Pregnant or breastfeeding females
- 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
- Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program
- 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:
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John D. Dingell VA Medical Center, Detroit, MI Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.