Recruiting

Rehabilitation InterventionsRehab and Mechanical Ventilation

Sponsor:

University of Florida

Code:

NCT07427121

Conditions

Inspiratory Strength Training (IST)

Transcutaneous Spinal Stimulation

Sham Spinal Stimulation

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Spinal cord stimulation

Inspiratory Strength Training

Sham Stimulation

Study Details

Brief 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

Study ID

NCT07427121

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Spinal cord stimulation

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

Inspiratory Strength Training

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

Sham Stimulation

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

Primary outcome measure

Maximal inspiratory pressure [ Time Frame: T1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MV ]
Phrenic CMAP Response [ Time Frame: up to 24 hours ]

Central Contacts and Locations

Central contacts

Barbara K Smith, PhD, PT

352-294-5315 bksmith@ufl.edu

Ushna Khan, MD

352-273-6855 ushnakhan@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Barbara K. Smith, PhD

352-294-5315 bksmith@phhp.ufl.edu

Ushna Khan, MD

352-294-5315 ushnakhan@phhp.edu

More Information

Sponsor

University of Florida

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

diaphragm
phrenic nerve
maximal inspiratory pressure
mechanical ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-05.