Exploring treatments for central sleep apnea
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
This study is testing new combination treatments for central sleep apnea in veterans to see if they can help improve breathing and quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT04118387 on ClinicalTrials.gov |
What this trial studies
This study investigates the physiological mechanisms underlying central sleep apnea (CSA) to inform future treatment strategies. It focuses on testing combination therapies, including positive airway pressure (PAP) alongside pharmacological agents like acetazolamide and zolpidem, in veterans with CSA. The goal is to identify effective multi-modality therapies that can normalize respiration and improve the quality of life for patients suffering from this condition. The study aims to provide insights that could guide future clinical trials and enhance care for individuals with CSA.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women veterans diagnosed with central sleep apnea, specifically those with an Apnea Hypopnea Index greater than 15 per hour.
Not a fit: Patients who are under 18 years old, pregnant, or have severe respiratory diseases requiring oxygen therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with central sleep apnea, improving their overall health and quality of life.
How similar studies have performed: While the approach of using combination therapies for CSA is being explored, the specific combination of treatments in this study is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * less than 18 years old * pregnant or breastfeeding female * have severe respiratory disease that require to be on oxygen * recent health event that may affect the ability to participate in the study, * Body Mass Index (BMI) is \>40 kg/m2 * significant insomnia * mental instability * recent health event that may affect sleep * if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: M Safwan Badr, MD — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: M S Badr, MD
- Email: sbadr@med.wayne.edu
- Phone: (313) 576-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.