STimulation to Activate RespIration (NCT06832306)
A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
🩺 Plain-English Summary (8th-Grade Level)
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).
Who can join: Review the eligibility criteria below.
Location: University of California San Diego — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- University of California San Diego — La Jolla, California
- Louisiana State University Health Sciences — Shreveport, Louisiana
- Wake Forest University School of Medicine — Winston-Salem, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Temple University — Philadelphia, Pennsylvania
- Prisma Health — Columbia, South Carolina
- University Health Network (UHN) — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (612) 986-7172
Email: mcotts@lungpacer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All ARDS (Moderate or Severe) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.