Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

NCT07739992 | Recruiting

• 1 other identifier: STU00226149
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

spinal cord injury; incomplete; Acute Intermittent Hypoxia

Outcome Measures

Primary Outcomes (2)

• Change in ankle plantarflexion and dorsiflexion

  Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate

  Immediately following Intervention

• Lower Limb Reaction time

  Assessed using visual, auditory, and combined cueing tasks, reaction time will be quantified as the time from cue presentation to muscle activity onset

  Immediately following intervention

Secondary Outcomes (2)

• SpO2 burden

  During intervention

• Hypoxic Ventilatory Response

  During intervention

Study Arms (3)

Sham + AIH 15 + AIH 23

OTHER

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

AIH 15 + Sham + AIH 23

OTHER

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

AIH 23 + AIH 15 + Sham

OTHER

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

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

Sham + AIH 15 + AIH 23

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

AIH 15 + Sham + AIH 23

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

AIH 23 + AIH 15 + Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milap Sandhu: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Insemination, Artificial, Homologous

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Milap Sandhu, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milap Sandhu, PhD, PT

CONTACT

312-238-6529; msandhu@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they are receiving AIH or Sham AIH
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, cross over design, participants will complete both arms

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 3 years of close of study
• Access Criteria: De-identified study data can be shared upon request by approved study staff

Locations

US (1)