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Combination Therapies for Central Sleep Apnea (CSA Trial)

Phase 4

Recruiting

Led By M Safwan Badr, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days

Awards & highlights

CSA Trial Summary

This trial is investigating ways to better treat central sleep apnea, a breathing disorder which is common in patients with heart failure or those using pain medications. Current treatment for central sleep apnea is positive airway pressure therapy, which is not very effective. The goal of this proposal is to find new, better ways to treat central sleep apnea by testing combination therapies including positive airway pressure and a pharmacological agent. The investigators hope that the findings of this trial will help to improve treatment and quality of life for Veterans suffering from central sleep apnea.

Who is the study for?

This trial is for Veterans with central sleep apnea, where they stop breathing frequently during sleep. Participants must have a specific severity of the condition and not be pregnant, breastfeeding, or have severe insomnia or respiratory diseases. They should also not be extremely overweight or mentally unstable.Check my eligibility

What is being tested?

The study tests if combining positive airway pressure (PAP) therapy with one of three drugs—Acetazolamide, Buspirone, or Zolpidem—can better treat central sleep apnea in patients with heart failure or those using opioid analgesics.See study design

What are the potential side effects?

Possible side effects from the treatments could include tingling sensations and dizziness from Acetazolamide; drowsiness and nausea from Buspirone; and daytime drowsiness or feeling 'drugged' after taking Zolpidem.

CSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran with central sleep apnea, with more than 15 breathing pauses per hour and more than 5 of those are central apneas.

CSA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CO2 reserve

Central apnea indices

Secondary outcome measures

% stable breathing

Carotid body function

Controller gain

+3 more

CSA Trial Design

3Treatment groups

Active Control

Group I: buspironeActive Control1 Intervention

To determine the effect of augmenting serotonin A1 receptor activity on breathing during sleep. The investigators hypothesize that administration of PAP and buspirone, a serotonin A1 receptor agonist; will reduce the propensity to central apnea during sleep in Veterans with CSA compared to PAP plus placebo.

Group II: acetazolamideActive Control1 Intervention

To determine the effect of dampening chemoreceptor sensitivity AND decreasing plant gain. The investigators hypothesize that combined therapy with PAP, acetazolamide and oxygen will be superior to PAP plus each intervention alone or placebo in reducing CAHI and the CO2 reserve during sleep in Veterans with CSA.

Group III: zolpidemActive Control1 Intervention

To determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of PAP and zolpidem, will decrease respiratory-related arousals, CAHI and the CO2 reserve during sleep in Veterans with CSA compared to PAP plus placebo.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,618 Previous Clinical Trials

3,315,973 Total Patients Enrolled

9 Trials studying Sleep Apnea

1,228 Patients Enrolled for Sleep Apnea

M Safwan Badr, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI

Media Library

buspirone Clinical Trial Eligibility Overview. Trial Name: NCT04118387 — Phase 4

Sleep Apnea Research Study Groups: buspirone, acetazolamide, zolpidem

Sleep Apnea Clinical Trial 2023: buspirone Highlights & Side Effects. Trial Name: NCT04118387 — Phase 4

buspirone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04118387 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions or symptoms is buspirone typically employed to manage?

"Usually, salicylate poisoning is managed with the medication buspirone. Additionally, this pharmaceutical agent can be prescribed to address edema, open angle glaucoma (OAG), and other types of glaucoma."

Answered by AI

Is buspirone accepted as a safe and efficacious therapeutic for humans?

"Based on the Phase 4 status of buspirone, our team at Power has assessed its safety as a 3. This classification indicates that this pharmaceutical is sanctioned for public use."

Answered by AI

What objectives do investigators seek to accomplish with this research endeavor?

"Over the course of 4 months, researchers will be monitoring several indices to ascertain the primary outcome: carbon dioxide reserve. Secondary measurements include % stable breathing (VE/VT coefficient), carotid body function (ventilation in response to 100% oxygen), and controller gain (ventilatory response to end-tidal PCO2)."

Answered by AI

What evidence exists for the efficacy of buspirone in other medical studies?

"Currently, 29 studies are being conducted to explore the medical efficacy of buspirone. 4 trials have reached Phase 3 and 43 sites throughout the United States are researching it, particularly in Silver Spring, Maryland."

Answered by AI

Is this research endeavor currently recruiting participants?

"According to the information found on clinicaltrials.gov, this research endeavour is open for participation and has been since it was first posted in early July 2021; its latest update date being December 27th of that same year."

Answered by AI

What is the scale of participation in this clinical trial?

"Affirmative. Clinicaltrials.gov verifies that this clinical trial is actively searching for participants; the initial post was made on July 1st, 2021 and recently updated on December 27th of the same year. Two hundred patients are sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment

2021. "Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04118387.

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