Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

Purpose

This study aims to evaluate how different doses of acute intermittent hypoxia (AIH) affect lower-limb strength, reaction time, and responsiveness in individuals with spinal cord injury (SCI). The objective is to identify the dose that most effectively improves motor output while also examining parameters that may account for variability in response.

Condition

  • Spinal Cord Injuries (SCI)

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic Spinal Cord Injury (>6 months) - Motor incomplete SCI classified as AIS C or D - Volitional ankle plantarflexion strength in at least one leg

Exclusion Criteria

  • Uncontrolled hypertension (outside 140/90 and 90/60) - Concurrent medical illness - Traumatic brain injury - Cardiovascular complications - Pulmonary complications - Metabolic dysfunction - Continued use of anti-spasticity medications - Previously diagnosed obstructive sleep apnea

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Randomized, cross over design, participants will complete both arms
Primary Purpose
Other
Masking
Single (Participant)
Masking Description
Participants will not know if they are receiving AIH or Sham AIH

Arm Groups

ArmDescriptionAssigned Intervention
Other
Sham + AIH 15 + AIH 23 		In this group, participants will undergo Sham AIH intervention first, with room oxygen, the following visit they will undergo 15, 60 second bouts of lowered oxygen, following that they will undergo 23, 60 second bouts of lowered oxygen
  • Other: Sham AIH
    In this intervention, participants will wear a fitted mask, and will be given 15 bouts of room air through the same delivery system as the AIH interventions
Other
AIH 15 + Sham + AIH 23 		In this group, participants will undergo15, 60 second bouts of lowered oxygen intervention first, the following visit they will undergo sham training with room air, following that they will undergo 23, 60 second bouts of lowered oxygen
  • Other: Acute Intermittent Hypoxia (AIH) 15
    In this intervention, participants will wear a fitted mask, and will be given 15, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air
Other
AIH 23 + AIH 15 + Sham 		In this group, participants will undergo 23, 60 second bouts of lowered oxygen intervention first, the following visit they will undergo 15, 60 second bouts of lowered oxygen, following that sham training with room air, following that they will undergo
  • Other: Acute Intermittent Hypoxia (AIH) 23
    In this intervention, participants will wear a fitted mask, and will be given 23, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air

Recruiting Locations

Shirley Ryan AbilityLab
Chicago, Illinois 60611
Contact:
Milap Sandhu, PT, PhD
312-238-6493
msandhu@sralab.org

More Details

Status
Recruiting
Sponsor
Milap Sandhu

Study Contact

Milap Sandhu, PhD, PT
312-238-6529
msandhu@sralab.org