Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
Key facts
- Who runs it
- Spaulding Rehabilitation Hospital
- Where
- Cambridge, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 30 people, planned
- Started
- Oct 2014
- Expected to end
- Nov 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SHAM - Intermittent Room Air - room air mixture
- AIH - Intermittent Hypoxia - hypoxia air mixture
- Record updated
- 20 March 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 18 to 75 years old (the latter to reduce likelihood of heart disease)
- medically stable with clearance from physician to participate
- motor---incomplete SCI at C2---L5 with non---progressive etiology
- >6 months since SCI to ensure minimal confounds of spontaneous neurological recovery
- those classified as ambulatory must have the ability to advance one step overground without human assistance
Who cannot take part
- concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs
- concurrent physical therapy
- less than 24 on the Mini-mental Exam
- recurrent autonomic dysreflexia
- cardiopulmonary complications
- pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded
Where in United States
- Spaulding Rehabilitation HospitalCambridge, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time.
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The investigators hypothesize:
* Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI) * AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI * AIH exposure will increase walking performance in persons with incomplete cervical SCI
The 2 groups in the trial
- Intermittent Hypoxia (AIH)Existing treatment, for comparison
Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen. Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes
Treatment: AIH - Intermittent Hypoxia - hypoxia air mixture
- Intermittent Room Air (SHAM)Sham treatment, for comparison
Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air. Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes
Treatment: SHAM - Intermittent Room Air - room air mixture
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Repetitive Exposure of Intermittent Hypoxia to Enhance Walking Recovery in Persons With Chronic Spinal Cord Injury
- Record updated
- 20 March 2026