Testing Combined Treatments for Central Sleep Apnea in Heart Failure

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Veterans with central sleep apnea, including people with stable heart failure. It tests positive airway pressure (PAP) therapy combined with a medicine or oxygen.

Age

18 years or older

Sex

Men and women

Disease stage

Central sleep apnea with AHI above 15 per hour and CAHI above 5 per hour. Heart failure, if present, must be chronic and stable with reduced ejection fraction, with no hospital stay or medicine change in the past 90 days.

Earlier treatment

No current treatment for central sleep apnea, including any positive airway pressure in the past three months. Must accept and keep using PAP during a one-week home trial after enrollment.

Main reasons for not taking part

• Pregnant or breastfeeding women
• Moderate or severe obstructive or restrictive lung disease, including use of extra oxygen
• History of heart rhythm problems
• Alcohol or substance abuse with less than 90 days of sobriety
• Depression or a history of suicidal thoughts

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• TrazodoneExisting treatment, for comparison

  To determine the effect of dampening respiratory arousals. The investigators hypothesize that positive airway pressure (PAP) therapy with trazodone at 100 milligrams will be superior to CPAP alone in widening the carbon dioxide (CO2) reserve during sleep, decreasing respiratory arousals, and increasing the arousal threshold.

  Treatment: Trazodone + positive airway pressure (PAP) therapy

• OxygenExisting treatment, for comparison

  To determine the effect of dampening peripheral chemoreceptor sensitivity. The investigators hypothesize that supplemental oxygen will be superior to CPAP alone in widening the carbon dioxide (CO2) reserve during sleep. The secondary analysis will use CAI as supplemental oxygen, which may obscure the detection of hypopneas based on desaturation.

  Treatment: Oxygen + positive airway pressure (PAP) therapy