Recruiting

Acute Intermittent Hypoxia

Sponsor:

Milap Sandhu

Code:

NCT07739992

Conditions

Spinal Cord Injuries (SCI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sham AIH

Acute Intermittent Hypoxia (AIH) 15

Acute Intermittent Hypoxia (AIH) 23

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries (SCI)

Study ID

NCT07739992

Start date

Jul 27, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

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

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

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

Primary outcome measure

  • Change in ankle plantarflexion and dorsiflexion [ Time Frame: Immediately following Intervention ]
  • Lower Limb Reaction time [ Time Frame: Immediately following intervention ]

Central Contacts and Locations

Central contacts

Milap Sandhu, PhD, PT

312-238-6529msandhu@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Milap Sandhu, PT, PhD

312-238-6493msandhu@sralab.org

Alexander Barry, MS

312-238-1435abarry@sralab.org

Principal Investigator:

Milap Sandhu, PT, PhD

More Information

Sponsor

Milap Sandhu

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • spinal cord injury
  • incomplete
  • Acute Intermittent Hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Milap Sandhu on 2026-07-31.