MedTrace Logo

Rehab and Mechanical Ventilation

NCT07427121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-05

No results posted yet for this study

Summary

The goal of this research study is to evaluate the effects of a single session of rehabilitation in healthy adults, before noninvasive mechanical ventilation (MV). MV can help support breathing function during sleep or illness. High levels of MV support have been reported to alter the function of the diaphragm muscle, the primary breathing muscle, in people with compromised health. However, rehabilitation may have some potential to improve diaphragm function in advance of using MV. This study will test different rehabilitation interventions, including (1) inspiratory strength training (IST), (2) transcutaneous spinal cord stimulation (TSCS), or sham TSCS. Before and after MV, participants will complete breathing strength tests and responses to phrenic nerve stimulation.

Conditions

  • Inspiratory Strength Training (IST)
  • Transcutaneous Spinal Stimulation
  • Sham Spinal Stimulation

Interventions

DEVICE

Spinal cord stimulation

Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.

BEHAVIORAL

Inspiratory Strength Training

5 sets of 5 breaths of high-intensity inspiratory strength training

OTHER

Sham Stimulation

Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Barbara K Smith, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2027-03-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07427121 on ClinicalTrials.gov