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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06011876
Other study ID # IRB202202891
Secondary ID W81XWH2210478
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2023
Est. completion date September 2027

Study information

Verified date January 2024
Source University of Florida
Contact Emily J Fox, PT, MHS, PhD
Phone 904-742-2500
Email ejfox@phhp.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (~15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.


Description:

This study will consist of two parts - single-session testing days, and respiratory strength training blocks. If a participant is not eligible to enroll in single-day testing, they will be asked to enroll in only the respiratory strength training blocks. On single-session testing days, participants will be asked to come in on three separate days they will complete a battery of tests, then be given one of three interventions, and then complete the same battery of tests. The three interventions are acute intermittent hypoxia (AIH), acute intermittent hypercapnic-hypoxia (AIHH), or sham acute intermittent hypoxia (sham AIH). These interventions are explained in more detail below. During respiratory strength training blocks, participants will receive five days of AIH, AIHH, or sham AIH in combination with respiratory strength training, which uses small hand-held devices to strengthen the muscles used for breathing. Participants will be asked to complete all three blocks to receive all three interventions. In addition to 5 days of interventions and respiratory strength training, the respiratory strength training blocks include testing 1 day, 3 days, and 7 days after the 5 days of respiratory strength training.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date September 2027
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Adults 18-70 years of age - Chronic SCI for > 1 year, at or below C-3 to T-12 - Incomplete SCI based on residual sensory or motor function below the level of the injury, or injury classification of B, C, D at initial screening, according to the American Spinal Injury Association Impairment Classification, and the International Standards for the Neurological Classification of SCI - Medically stable with physician clearance - SCI due to non-progressive etiology - 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values Exclusion Criteria: - Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury - Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension - Severe neuropathic pain - Known pregnancy - Severe recurrent autonomic dysreflexia Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acute Intermittent Hypoxia (AIH)
AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).
Acute Intermittent Hypercapnic-Hypoxia (AIHH)
AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).
Sham AIH
A single session of sham AIH with episodes of normal room air (21% O2).

Locations

Country Name City State
United States Brooks Rehabilitation Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida U.S. Army Medical Research Acquisition Activity

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in motor evoked potential The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation. Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
Primary Change in maximal inspiratory pressure Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway. Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.)
Primary Change in maximal expiratory pressure Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway. Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.)
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