Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury (NCT02274116) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
United States30 participantsStarted 2014-10
Plain-language summary
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.
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* less than 24 on the Mini-mental Exam;
* recurrent autonomic dysreflexia
* cardiopulmonary complications
* concurrent physical therapy
* pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in overground walking endurance
Timeframe: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks