NCT06011876

BioFLO for Respiratory Recovery in SCI

Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-12-21
• Primary completion: 2027-07-01
• Completion: 2027-09-01
• First posted: 2023-08-25
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States