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Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

ConditionsSleep Disordered BreathingAble Bodied
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

less than 18 years old

pregnant or breastfeeding females

moderate or severe obstructive or restrictive lung disease, including supplemental o2 use

current treatment for CSA, including any form of PAP in the past three months, or phrenic nerve situation.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Trazodone + PAP therapy

    Drug

    The central apnea index and the apneic threshold will be compared under two conditions: trazodone or placebo. In addition, participants will get PAP therapy during both the conditions.

  • Oxygen + PAP therapy

    Drug

    The central apnea index and the apneic threshold will be compared under two conditions: oxygen or room air. In addition, participants will get PAP therapy during both the conditions.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: TrazodoneActive comparator 1 intervention
Group B: OxygenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

CO2 Reserve

CO2 reserve is the requisite change to induce central apnea to as the CO2 reserve, which can be positive or negative.

Time frame
120 days

Secondary outcomes

1

Peripheral Chemoresponsiveness

Peripheral chemoreflex sensitivity/Peripheral chemoresponsiveness is measured either via brief hypoxia or a single breath of CO2.

Time frame
120 days
2

Arousal Threshold

Arousal threshold is a measure of the upper airway muscle response to an obstructive sleep event.

Time frame
120 days
3

Carotid body function

This measure represents the activity of the carotid bodies. It is measured by the decrease in ventilation in response to a single breath of 100% oxygen.

Time frame
120 days
4

Controller gain

Controller gain is a ventilatory response to changes in end-tidal PCO2.

Time frame
120 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: