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BioFLO for Respiratory Recovery in SCI

NCT06011876 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

Acute Intermittent Hypoxia (AIH)

AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).

OTHER

Acute Intermittent Hypercapnic-Hypoxia (AIHH)

AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).

OTHER

Sham AIH

A single session of sham AIH with episodes of normal room air (21% O2).

Sponsors & Collaborators

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • University of Florida

    lead OTHER

Principal Investigators

  • Emily Fox, DPT, MHS, PhD · University of Florida & Brooks Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2027-07-31
Completion
2027-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011876 on ClinicalTrials.gov