FLO2 for Recovery After SCI

Spinal Cord Injury (SCI) Clinical Trial

Official title:

Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833674
• Other study ID #: IRB201802672
• Secondary ID: W81XWH-18-1-0718
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: February 20, 2024

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute intermittent hypoxia (AIH) involves short (~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.

Description:

Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing muscle paralysis and decreased breathing capacity. Since respiratory impairment is the major cause of illness and death with SCI, it is critical to devise new strategies to restore breathing function.

Repetitive exposure to brief episodes of low oxygen (acute intermittent hypoxia or AIH) has demonstrated to increase respiratory function in humans with chronic SCI. Additionally pre-clinical studies demonstrate that AIH-induced functional benefits are enhanced by combining AIH with task-specific training. The investigator's central hypothesis is that combined daily AIH (dAIH) and respiratory strength training will elicit greater and more sustained gains in respiratory function than either treatment alone in people with chronic SCI.

This study is a double-blind, randomized, cross-over design where participants will complete 4 random-ordered blocks, consisting of a 5-day intervention followed by a 3-week washout period, during which 1-day, 3-day, and 1-week post-tests will be conducted. Participants will include 53 adults with chronic, incomplete SCI with >20% respiratory impairment based on maximal inspiratory or expiratory pressure generation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic incomplete SCI for = 1 year at or below C-1 to T-12

• Incomplete SCI based on residual sensory and 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

-OR-

Chronic complete SCI for = 1 year at or below C-4 to T-12

• Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A 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 clearance from physician

• SCI due to non-progressive etiology

• >20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values.

Exclusion Criteria:

• Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury

• Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction, <1 year lung disease, infections, hypertension, heterotopic ossification.

• Severe neuropathic pain

• Known pregnancy

• Severe recurrent autonomic dysreflexia

• History of seizure disorder < 1 year

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury (SCI)

Intervention

Other:
• Daily AIH Block
Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
• Sham dAIH Block
Daily sessions of sham dAIH which includes breathing room air (21% O2)
• Respiratory Strength Training Block
Respiratory strength training using a hand-held device that resists inspiration or expiration.
• AIH + Strength Training Block
AIH followed by respiratory strength training.

Locations

Country	Name	City	State
United States	Brooks Rehabilitation Hospital	Jacksonville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Brooks Rehabilitation, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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, Day 1, Day 6, Day 8, Day 15
Primary	Change in maximal expiratory pressure	Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.	Baseline, Day 1, Day 6, Day 8, Day 15