Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function

University of Colorado Boulder (CU)

Status: Invitation-only

Conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D); Able Bodied

Treatments: Other: Acute Intermittent Hypoxia (AIH)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06906536

1R03HD115657-01 (U.S. NIH Grant/Contract)

23-1275

Details and patient eligibility

About

The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.

Full description

The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 75 years old (the latter to reduce likelihood of heart disease)
• Medically stable with medical clearance from physician to participate
• Motor-incomplete spinal cord injuries at or below C2 and at or above L5
• AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
• More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
• Ability to advance one step overground with or without assistive devices;

Exclusion criteria

• Severe concurrent illness or pain
• Recurrent autonomic dysreflexia
• History of cardiovascular/pulmonary complications
• Concurrent physical therapy
• Pregnant at time of enrollment or planning to become pregnant
• Untreated painful musculoskeletal dysfunction, fracture or pressure sore
• History of seizures or epilepsy
• Recurring headaches
• Concussion within the last six months
• Depression or manic disorder
• Metal implants in the head, or pacemaker
• Aversion to needles

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

AIH Group

Experimental group

Description:

Participants will be exposed to 4 consecutive days of acute intermittent hypoxia (AIH): 15, 1.5 min episodes at 9% O2 alternating with 21% O2 at 1 min intervals.

Treatment:

Other: Acute Intermittent Hypoxia (AIH)

SHAM Group

No Intervention group

Description:

Participants will be exposed to 4 consecutive days of normoxia: 15, 1.5 min episodes at 21% O2 alternating with 21% O2 at 1 min intervals.