RightFit
RecruitingPhase 4

Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests combined treatments for central sleep apnea, when breathing stops and starts during sleep. Treatments include air pressure through a mask (PAP) plus medicine. It focuses on Veterans with heart failure or those who use opioid pain medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Veterans of any sex with central sleep apnea: more than 15 breathing pauses or shallow breaths per hour, including more than 5 linked to central sleep apnea.
  • Long-term, stable heart failure with a weak heart pump. Heart failure treatment must follow care guidelines, with no medicine changes or hospital stays in the past 90 days.

Who can't join

  • Pregnant or breastfeeding.
  • Moderate or severe lung disease that limits airflow or lung expansion, or use of extra oxygen.
  • Current treatment for central sleep apnea, including any PAP use in the past 3 months.
  • Too ill to take part, unable to give consent, or a history of abnormal heart rhythms.
  • Alcohol or drug abuse with less than 90 days sober, current addiction treatment, depression, or a history of suicidal thoughts or actions.
  • Severe trouble sleeping, with an Insomnia Severity Index score above 21, or sleeping less than 6 hours.
  • Central sleep apnea that starts with PAP, or not accepting or regularly using PAP during a one-week home trial after joining.
  • For trazodone: a heart tracing showing a prolonged QT (an electrical timing problem), medicines that block the enzyme CYP3A4, or severe kidney disease with a filtering rate below 20 or end-stage kidney disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MI