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Behavioural Intervention

Repetitive Acute Intermittent Hypoxia for Spinal Cord Injury

Led By Monica A Perez, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SCI at or above L2
ASIA A, B, C, or D, complete or incomplete
Screening 3 weeks
Treatment Varies
Follow Up 5-10 minutes
Awards & highlights

Study Summary

This trial is testing if a treatment of acute intermittent hypoxia, or periods of low oxygen, can help improve function in people with chronic spinal cord injury.

Who is the study for?
This trial is for adults aged 18-85 with chronic spinal cord injury at or above L2, who can grip with one hand or move their wrist and ankle slightly. It's not for those with uncontrolled medical issues, recent heart problems, pregnancy, seizure history, certain medication use, previous brain injuries or conditions affecting the spine other than SCI.Check my eligibility
What is being tested?
The study tests whether repeated sessions of acute intermittent hypoxia (brief periods of low oxygen) combined with upper and lower limb training can improve limb function in people with long-term spinal cord injuries.See study design
What are the potential side effects?
Potential side effects may include discomfort from low oxygen levels like headache or shortness of breath during the hypoxia exposure. Training might cause muscle soreness. There's also a risk of seizures due to fluctuating oxygen levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My spinal cord injury is at or above the L2 level.
My spinal cord injury is classified as ASIA A, B, C, or D.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-10 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EMG and force voluntary output
Lower limb functional measurement
MEP/CMEP recruitment curves using TMS
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: rAIH + training by research staffActive Control3 Interventions
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
Group II: sham rAIH + trainingPlacebo Group3 Interventions
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.

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Who is running the clinical trial?

U.S. Department of EducationFED
86 Previous Clinical Trials
54,672 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
198 Previous Clinical Trials
17,019 Total Patients Enrolled
Monica A Perez, PhDPrincipal InvestigatorShirley Ryan AbilityLab
3 Previous Clinical Trials
303 Total Patients Enrolled

Media Library

Repeated exposure to acute Intermittent Hypoxia (rAIH) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03433599 — N/A
Spinal Cord Injury Research Study Groups: sham rAIH + training, rAIH + training by research staff
Spinal Cord Injury Clinical Trial 2023: Repeated exposure to acute Intermittent Hypoxia (rAIH) Highlights & Side Effects. Trial Name: NCT03433599 — N/A
Repeated exposure to acute Intermittent Hypoxia (rAIH) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03433599 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking to include test subjects who are above the age of forty?

"This clinical trial is accepting applicants above the age of majority but below 85 years old."

Answered by AI

Who fulfills the criteria for participating in this trial?

"The clinical trial is looking for 60 people with spinal cord injuries in the 18-85 age range."

Answered by AI

Is recruitment of participants still open for this experiment?

"Research posted on clinicaltrials.gov states that this medical trial is currently recruiting participants. With the initial posting date of April 9th 2020 and last edit being June 28th 2022, recruitment is still in process."

Answered by AI

What is the maximal quantity of participants in this research?

"Affirmative. Clinicaltrials.gov affirms that this medical experiment, first posted on April 9th 2020, is recruiting patients at present. Approximately 60 volunteers need to be enrolled from 1 healthcare centre."

Answered by AI
~7 spots leftby Dec 2024