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 — OTHER
    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
  • Acute Intermittent Hypoxia (AIH) 15 — OTHER
    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
  • Acute Intermittent Hypoxia (AIH) 23 — OTHER
    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

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 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: 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: 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

Primary Outcome Measure

Change in ankle plantarflexion and dorsiflexion [ Time Frame: Immediately following Intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Milap Sandhu, PT, PhD
312-238-6493
Alexander Barry, MS
312-238-1435
Milap Sandhu, PT, PhD (PRINCIPAL_INVESTIGATOR)

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