Diaphragm IssuesNCT05883163
STIMIT Activator 1 IDE Study
A study testing Stimit Activator 1 in people with Diaphragm Issues, run by Stimit AG at 4 sites in 2 countries.
Trial summary
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diaphragm Issues
- What is being tested?
- Stimit Activator 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Jan 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 21 years or older, and,
- 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
- Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization
Who cannot join
- Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
- 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).
- Any patients with ICP probe.
- 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.
- 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.
- BMI >40.
Show all 14Show fewer
- Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
- Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
- Known to be pregnant.
- Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
- 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).
- 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).
- Patients with significant spontaneous efforts (P0.1 < - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Matthew Killam, mkillam@bidmc.harvard.edu
Elias Baedorf Kassis, MD
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Hailey Russo, SXU9RN@uvahealth.org
Danny J. Theodore, MD
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Rodolfo Nelson Molina, Rodolfo.molina@yale.edu
Pramod Bonde, MD, FACS
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital Unity Health Toronto
Toronto
Marlene Santos-Taylor, Marlene.Santos@unityhealth.to
Laurent Brochard, MD
About this study
Official title: STIMIT Activator 1 Pivotal Study
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.
Read the detailed description
The objective of this clinical investigation is to evaluate the safety and effectiness of the STIMIT Activator 1 System in patients who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy.
The study is expected to enroll 40 participants at up to 8 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 participants have been enrolled and compelted their study follow-up to reconfirm sample size (adaptive design). Participants will be followed for up to 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.
- Conditions
- Diaphragm Issues
- Being tested
- Stimit Activator 1
- Keywords
- Non-Invasive Phrenic Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimit Activator 1Device
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Group | Experimental | The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm. Receives: Device: Stimit Activator 1 |
| Control Group | No intervention | The control group will not received intervention and will be treated with standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efffectiveness: Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Measured: Up to Day 10
Safety: Rate of device or procedure related serious adverse events (SAEs)
Events will be collected for intervention group during the course of treatment.
Measured: Up to Day 10
Secondary outcomes (3)
Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Measured: Up to Day 3
Time to Rapid Shallow Breathing Index (RSBI) < 105
Time from intubation to RSBI<105 breaths/min/L in days will be compared between intervention and control groups.
Measured: Up to Day 10
Maximum Inspiratory Pressure (MIP) at extubation
MIP at extubation will be compared between intervention and control groups.
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start24 Jan 2024
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center, 1:1 randomized, controlled study using adaptive design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stimit AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Brochard, MD, Principal investigator, St Michael's Hospital Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883163
- Sponsor's protocol ID
- D-26606
- Status last verified
- Nov 2025
- First submitted
- 20 May 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schreiber AF, Subira C, Sklar M, Santos M, Ko M, Panelli A, Schaller SJ, Theodore D, Rowley DD, Watson D, Bonde P, Baedorf Kassis EN, Talmor DS, Ranieri M, Goligher EC, Slutsky A, Brochard LJ. Multi-center randomized superiority clinical trial in the early phase of mechanically ventilated patients to preserve diaphragm thickness using non-invasive magnetic phrenic nerve stimulation: STIMIT ACTIVATOR 1 pivotal trial. Trials. 2025 Jun 11;26(1):202. doi: 10.1186/s13063-025-08838-2.
PubMed 40500715
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STIMIT Activator 1 Pivotal Study
- ClinicalTrials.gov ID
- NCT05883163
- Acronym / sponsor ID
- D-26606
- Conditions
- Diaphragm Issues
- Keywords
- Non-Invasive Phrenic Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stimit AGIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.
Detailed description
The objective of this clinical investigation is to evaluate the safety and effectiness of the STIMIT Activator 1 System in patients who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy.
The study is expected to enroll 40 participants at up to 8 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 participants have been enrolled and compelted their study follow-up to reconfirm sample size (adaptive design). Participants will be followed for up to 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, 1:1 randomized, controlled study using adaptive design
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | Experimental | Device: Stimit Activator 1The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm. |
| Control Group | No intervention | –The control group will not received intervention and will be treated with standard of care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are 21 years or older, and,
- 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
- Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization
Key exclusion criteria (14 listed)
- Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
- 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).
- Any patients with ICP probe.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimit Activator 1The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation. | Device | Stimulation Group |
Primary outcome
Efffectiveness: Preservation of Diaphragm Thickness
Time frame: Up to Day 10
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Safety: Rate of device or procedure related serious adverse events (SAEs)
Time frame: Up to Day 10
Events will be collected for intervention group during the course of treatment.
3 secondary outcomes
Preservation of Diaphragm Thickness
Time frame: Up to Day 3
Time to Rapid Shallow Breathing Index (RSBI) < 105
Time frame: Up to Day 10
Maximum Inspiratory Pressure (MIP) at extubation
Time frame: Up to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Derived from this study: PubMed 40500715Schreiber AF, Subira C, Sklar M, Santos M, Ko M, Panelli A, Schaller SJ, Theodore D, Rowley DD, Watson D, Bonde P, Baedorf Kassis EN, Talmor DS, Ranieri M, Goligher EC, Slutsky A, Brochard LJ. Multi-center randomized superiority clinical trial in the early phase of mechanically ventilated patients to preserve diaphragm thickness using non-invasive magnetic phrenic nerve stimulation: STIMIT ACTIVATOR 1 pivotal trial. Trials. 2025 Jun 11;26(1):202. doi: 10.1186/s13063-025-08838-2.
Related trials for Diaphragm Issues
RecruitingObservational study
Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Diaphragm Issues, Mechanical Ventilation Complication
Not yet recruitingObservational study
Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis
Diaphragm Issues
Not yet recruiting
Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function
Diaphragm Issues
Not yet recruitingObservational study
The Effect of BIPAP on Diaphragmatic Function
BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Brochard, MD principal investigator
St Michael's Hospital Unity Health Toronto
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimit Activator 1 in people with Diaphragm Issues, run by Stimit AG at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsiry Rabemahefa (218-329-7356, tsiry.rabemahefa@stimit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efffectiveness: Preservation of Diaphragm Thickness (time frame: Up to Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.