← Back to Search

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
Must not have
Significant insomnia
Less than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days
Awards & highlights

Summary

This trial tests a combination of a machine that keeps airways open and medications to improve breathing in patients with central sleep apnea who have heart failure or use opioid painkillers. The goal is to make breathing more stable and less sensitive to disruptions during sleep. A specific type of machine has been studied as a treatment for central sleep apnea in heart failure patients, showing mixed results in improving outcomes.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe trouble sleeping.
Select...
I am under 18 years old.
Select...
I need oxygen therapy for my severe respiratory condition.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CO2 reserve
Central apnea indices
Secondary study objectives
% stable breathing
Carotid body function
Controller gain
+3 more

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Sleep Apnea include Positive Airway Pressure (PAP) therapy and pharmacological agents. PAP therapy, such as CPAP, APAP, and ASV, works by delivering continuous or variable air pressure to keep the airways open during sleep, preventing apneas and improving oxygenation. Pharmacological agents may target underlying conditions like heart failure or opioid-induced central sleep apnea. Combining these therapies can address both mechanical obstructions and physiological factors, potentially leading to more effective and comprehensive management of Sleep Apnea, improving patient outcomes and quality of life.
Sleep apnea and pulmonary hypertension: A riddle waiting to be solved.Non-invasive ventilation for obese patients with chronic respiratory failure: Are two pressures always better than one?Current Treatment of Comorbid Insomnia and Obstructive Sleep Apnea With CBTI and PAP-Therapy: A Systematic Review.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,656 Previous Clinical Trials
3,361,358 Total Patients Enrolled
9 Trials studying Sleep Apnea
1,106 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
~30 spots leftby Jun 2025