Actively Recruiting
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
Led by VA Office of Research and Development · Updated on 2026-03-13
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying central sleep apnea (CSA), a common condition in patients with heart failure and those using opioid pain medications, which is difficult to treat with current methods. The study aims to understand how combination therapies can improve breathing during sleep by targeting different physiological pathways. It focuses on using positive airway pressure (PAP) together with medications to reduce central apnea events and improve respiratory function in Veterans with CSA. The trial tests three combination therapies alongside PAP: acetazolamide plus supplemental oxygen, zolpidem, and buspirone. Each treatment is compared to placebo or individual components to see which best lowers the central apnea-hypopnea index (CAHI) and improves CO2 reserve during sleep. Participants will receive PAP therapy throughout the study while also receiving one of the medication combinations or placebo in a randomized, double-blind design. Participants will be evaluated with measurements including the central apnea index, apneic threshold, CO2 reserve, and various respiratory control factors over 120 days. Assessments will include sleep studies and physiological tests to monitor breathing patterns and response to treatment. The study will also track safety and adherence to the therapies. Findings aim to guide future clinical trials and improve care for Veterans with central sleep apnea.
CONDITIONS
Brief Title
Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women Veterans with central sleep apnea defined as Apnea Hypopnea Index (AHI) >15/hour with CAHI >5/hour
You will not qualify if you...
- Under 18 years old
- Pregnant or breastfeeding female
- Severe respiratory disease requiring oxygen therapy
- Recent health event affecting ability to participate
- Body Mass Index (BMI) greater than 40 kg/m2
- Significant insomnia
- Mental instability
- Recent health event affecting sleep
- Unsuitable for study drugs or unable to use PAP device as determined by principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 days
Participants receive different combination therapies involving PAP therapy with acetazolamide plus supplemental oxygen, zolpidem, or buspirone to reduce central apnea during sleep.
Multiple visits depending on treatment crossover schedule
Trial Site Locations
Total: 1 location
1
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201-1916
Actively Recruiting
Research Team
M
M S Badr, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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