Rehab and Mechanical Ventilation

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07427121
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Spinal cord stimulation — DEVICE
    Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
  • Inspiratory Strength Training — BEHAVIORAL
    5 sets of 5 breaths of high-intensity inspiratory strength training
  • Sham Stimulation — OTHER
    Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.

Study Details

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.

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Stimulation
    Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
  • Active Comparator: Spinal cord stimulation
    Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
  • Experimental: Inspiratory strength training
    5 sets of 5 breaths of high-intensity inspiratory strength training

Primary Outcome Measure

Maximal inspiratory pressure [ Time Frame: T1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MV ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Barbara K. Smith, PhD
[email protected]
352-294-5315
Ushna Khan, MD
[email protected]
352-294-5315

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