Rehabilitation to protect the diaphragm before mechanical ventilation.
Official title: Rehabilitation-based Approaches to Prevent Mechanical Ventilation-induced Breathing Dysfunction
Run by University of Florida · NCT07427121 · Data updated 2026-11-12
This study will test whether a single session of inspiratory strength training or noninvasive spinal stimulation helps healthy adults keep diaphragm strength before a short period of mechanical ventilation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 80 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07427121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy, non-smoking adults with normal lung function who are sedentary or recreationally active and who do not use positive airway pressure devices or have claustrophobia or contraindicated implants.
✕Probably not a fit
People with obstructive lung disease, current smoking or vaping, active systemic infection or sepsis history, neuromuscular or neurological diagnoses, need for supplemental oxygen or CPAP, cardiac or significant orthopedic conditions, pregnancy, or metallic implants near the cervical spine are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Healthy, non-smoking adults undergo baseline breathing strength tests and phrenic nerve stimulation measures, then receive one of three interventions: inspiratory strength training (IST), transcutaneous spinal cord stimulation (TSCS), or sham TSCS. Participants then experience a brief period of noninvasive mechanical ventilation with repeat measurements taken immediately before and after ventilation. The single-session interventional design compares physiological effects of the interventions on diaphragm contractility and respiratory neural drive. The focus is on immediate changes in inspiratory strength and neural responses rather than long-term clinical outcomes.
Why it matters
Potential benefit: If successful, these approaches could help preserve diaphragm strength around episodes of mechanical ventilation and reduce breathing-related complications after surgery or illness.
How similar studies have gone: Prior work shows inspiratory muscle strength training reliably improves diaphragm strength, while transcutaneous spinal stimulation for this specific application is less established and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Non-smokers Sedentary or recreationally active Normal lung function No history of claustrophobia Exclusion Criteria: Current smoking or vaping Obstructive lung disease Use of antibiotics or systemic corticosteroids to treat an acute condition History of sepsis or metastatic disease Post infectious conditions that affect breathing Diagnosed with a neurological or neuromuscular condition Any use of supplemental oxygen, continuous positive airway pressure (CPAP), or other positive pressure ventilation to treat sleep apnea Cardiac disease Orthopedic conditions that impair lung expansion Pregnancy Implanted metallic devices within 10 cm of the cervical spine
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Barbara K Smith, PhD — University of Florida
- Study coordinator: Barbara K Smith, PhD, PT
- Email: bksmith@ufl.edu
- Phone: 352-294-5315
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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.