Menu
Recruiting NCT07739992

Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

No phase Interventional Spinal Cord Injuries (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham AIH, Acute Intermittent Hypoxia (AIH) 15, Acute Intermittent Hypoxia (AIH) 23.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dose-Optimization Study of Acute Intermittent Hypoxia (DOSA-SCI): Effects on Lower-Limb Motor Function and Physiological Responsiveness in Individuals With Incomplete Spinal Cord Injury

Overview

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.

Interventions

  • 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 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 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 measures

  • Change in ankle plantarflexion and dorsiflexion [Time frame: Immediately following Intervention]
  • Lower Limb Reaction time [Time frame: Immediately following intervention]
Secondary outcome measures (2)
  • SpO2 burden [Time frame: During intervention]
  • Hypoxic Ventilatory Response [Time frame: During intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT07739992 · STU00226149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗