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RecruitingAccepts healthy volunteersPhase 4

Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

VA Office of Research and Development · NCT07210606

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
200
US sites recruiting
1
Study start
September 16, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Trazodone + positive airway pressure (PAP) therapy; Oxygen + positive airway pressure (PAP) therapy

Conditions: Sleep Disordered Breathing; Able Bodied

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • John D. Dingell VA Medical Center, Detroit, MI

    Detroit, MI 48201-1916

    Site contact: M S Badr, MD · (313) 576-1000 · sbadr@med.wayne.edu

Study contacts (from the official record)

  • M S Badr, MD · (313) 576-1000 · sbadr@med.wayne.edu
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Central Apnea in Heart Failure: Physiological Mechanisms to Inform… (NCT07210606) | Bored Studies