FLO2 for Recovery After SCI

NCT03833674 | Completed

• 2 other identifiers: IRB201802672W81XWH-18-1-0718
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury (SCI)

Keywords

acute intermittent hypoxia (AIH); spinal neuroplasticity; motor function; respiratory strength training; respiration; breathing; plasticity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Adults with incomplete SCI

EXPERIMENTAL

Adults with chronic, incomplete SCI who have \>20% impairment in respiratory function, who will complete a battery of clinical assessments and 4 randomly ordered intervention and testing blocks (Daily AIH Block, Sham dAIH Block, Respiratory Strength Training Block and AIH + Strength Training Block).

Other: Daily AIH Block; Other: Sham dAIH Block; Other: Respiratory Strength Training Block; Other: AIH + Strength Training Block

Interventions

Daily AIH Block OTHER

Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)

Also known as: dAIH Block

Adults with incomplete SCI

Sham dAIH Block OTHER

Daily sessions of sham dAIH which includes breathing room air (21% O2)

Adults with incomplete SCI

Respiratory Strength Training Block OTHER

Respiratory strength training using a hand-held device that resists inspiration or expiration.

Adults with incomplete SCI

AIH + Strength Training Block OTHER

AIH followed by respiratory strength training.

Adults with incomplete SCI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• United States Department of Defense: collaborator
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, United States

Location

Related Publications (1)

• Welch JF, Vose AK, Cavka K, Brunetti G, DeMark LA, Snyder H, Wauneka CN, Tonuzi G, Nair J, Mitchell GS, Fox EJ. Cardiorespiratory Responses to Acute Intermittent Hypoxia in Humans With Chronic Spinal Cord Injury. J Neurotrauma. 2024 Sep;41(17-18):2114-2124. doi: 10.1089/neu.2023.0353. Epub 2024 Apr 18.

  PMID: 38468543 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Aspiration

Interventions

Insemination, Artificial, Homologous

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Emily Fox, PT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Gordon Mitchell, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and the clinical evaluator will be informed of possible interventions but will be blinded to the gas mixture (hypoxic vs normoxic air) used during each AIH intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete a battery of clinical assessments and 4 randomly ordered intervention and testing blocks. Blocks 1, 2 and 3 include a 5 day intervention (e.g., dAIH and/or respiratory training) or sham protocol, followed by a 3-week washout period, with follow up measurements at 1 day, 3 days and 1 week post-intervention. The final block includes a 5-day protocol followed by 1-day, 3-day and 1-week post-tests.

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: August 15, 2020
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)