Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Milap Sandhu
- Study ID
- NCT07739992
- Status
- Recruiting
Conditions
- Spinal Cord Injuries (SCI)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sham AIH — OTHERIn 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
- Acute Intermittent Hypoxia (AIH) 15 — OTHERIn 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
- Acute Intermittent Hypoxia (AIH) 23 — OTHERIn 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
Study Details
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.
Key Dates
- First listed
- Jul 31, 2026
- Start date
- Jul 27, 2026
- Status verified
- Jul 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Other: Sham + AIH 15 + AIH 23In 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: AIH 15 + Sham + AIH 23In 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: AIH 23 + AIH 15 + ShamIn 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
Primary Outcome Measure
Change in ankle plantarflexion and dorsiflexion [ Time Frame: Immediately following Intervention ]
Central Contacts
- Milap Sandhu, PhD, PT312-238-6529
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | Milap Sandhu, PT, PhD (PRINCIPAL_INVESTIGATOR) |
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