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NOT YET RECRUITING
NCT07210606
PHASE4

Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-10-01

Completion Date

2030-12-31

Last Updated

2026-01-07

Healthy Volunteers

Yes

Interventions

DRUG

Trazodone + PAP therapy

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.

DRUG

Oxygen + PAP therapy

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.

Locations (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States