BioFLO for Respiratory Recovery in SCI

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT06011876
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 21, 2023
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Single-session testing days
    Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.
  • Experimental: Respiratory strength training blocks
    Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.

Primary Outcome Measure

Change in motor evoked potential [ Time Frame: Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooks RehabilitationJacksonvilleFlorida32216
Emily J. Fox, MHS, DPT, PhD
[email protected]
(904) 742-2500

Find similar trials in Jacksonville, FL

By research site
Brooks Rehabilitation· Jacksonville, FL

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