Non-invasive treatment for diaphragm issues in ventilated patients
Official title: STIMIT Activator 1 Pivotal Study
Run by Stimit AG · NCT05883163 · Data updated 2026-11-12
This study is testing a new non-invasive device to see if it can help patients who are on a ventilator for breathing issues get better and breathe on their own again.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Stimit AG Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Status | Recruiting |
| Started | January 24, 2024 |
| Main results expected | April 2026 |
| Study ends | July 2026 |
| Registry record updated | November 14, 2025 |
| Trial ID | NCT05883163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who have been on invasive mechanical ventilation for 48 hours or less and are predicted to need it for at least another 48 hours.
✕Probably not a fit
Patients who are planned to receive continuous neuromuscular blocking agents beyond the enrollment period or have severe chronic pulmonary diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation evaluates the safety and efficacy of the STIMIT Activator 1 device in patients who have been on invasive mechanical ventilation for up to 48 hours and are expected to require additional ventilation. The study is a prospective, multi-center, randomized, controlled trial using an adaptive design, aiming to include 40 subjects across up to 6 centers primarily in the USA. An interim analysis will be conducted after 30 patients to confirm the sample size, with a follow-up period of 10 days or until successful extubation. The study is anticipated to commence upon regulatory approvals.
Why it matters
Potential benefit: If successful, this treatment could improve diaphragm function and reduce the duration of mechanical ventilation for patients.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in non-invasive stimulation techniques for respiratory issues.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Are 21 years or older, and, 2. Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV 3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization Exclusion Criteria: 1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period. 2. Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below). 3. Any patients with ICP probe. 4. Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation. 5. Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants. 6. BMI \>40. 7. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period. 8. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor. 9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care. 10. Known to be pregnant. 11. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome. 12. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed). 13. Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns). 14. Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.
Where it's running
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Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
University of Virginia Medical Center
Charlottesville, Virginia, United States Recruiting -
St Michael's Hospital Unity Health Toronto
Toronto, Canada Recruiting
Study contacts
- Principal investigator: Laurent Brochard, MD — St Michael's Hospital Unity Health Toronto
- Study coordinator: Tsiry Rabemahefa
- Email: tsiry.rabemahefa@stimit.com
- Phone: 218-329-7356
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How diaphragm strength changes during and after mechanical ventilation
This project will try to see how quickly the diaphragm weakens in ICU patients on mechanical ventilation and whether it recovers after they are taken off the ventilator.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.