RecruitingPhase 4NCT04118387

Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment

Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment


Sponsor

VA Office of Research and Development

Enrollment

200 participants

Start Date

Jan 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetazolamide + supplemental oxygen + PAP therapy, a drug called Buspirone + PAP therapy, and others for people with able bodied and sleep-disordered breathing. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcetazolamide + supplemental oxygen + PAP therapy

Every participant will undergo measurement of the apneic threshold. The apneic threshold (AT) can be determined by inducing central apnea using non-invasive ventilation (NIV) or eliminating central apnea using supplemental CO2. The requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative. The central apnea index and the apneic threshold will be measured while participants receiving medication or oxygen (or both). In addition, participants will get PAP therapy during all the conditions.

DRUGZolpidem + PAP therapy

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

DRUGBuspirone + PAP therapy

The central apnea index and the apneic threshold will be compared under two conditions: buspirone or placebo. 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

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NCT04118387


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