NCT04118387 Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment
| NCT ID | NCT04118387 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Sleep Disordered Breathing |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-01-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2021-01-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
M Safwan Badr, MD
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT04118387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Disordered Breathing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04118387 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04118387 currently recruiting?
Yes, NCT04118387 is actively recruiting participants. Contact the research team at sbadr@med.wayne.edu for enrollment information.
Where is the NCT04118387 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT04118387 clinical trial?
NCT04118387 is sponsored by VA Office of Research and Development. The principal investigator is M Safwan Badr, MD at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 200 participants.