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Mild Intermittent Hypoxia for Spinal Cord Injury (MIH and AD Trial)
N/A
Recruiting
Led By Gino Panza, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-60
Motor incomplete spinal cord injury at or above the 6th thoracic vertebrae
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention, 1 day after intervention, 2 weeks after intervention
Awards & highlights
MIH and AD Trial Summary
This trial will investigate whether mild intermittent hypoxia can help prevent autonomic dysfunction and sleep disordered breathing, which are increased in individuals with spinal cord injury.
Who is the study for?
This trial is for individuals aged 18-60 with motor incomplete spinal cord injuries above the 6th thoracic vertebrae and signs of autonomic dysfunction. It's not for those with complete SCI, injuries below T6, disrupted sleep patterns, pregnancy, smokers, drug addiction, age outside the specified range or active skin sores.Check my eligibility
What is being tested?
The study tests mild intermittent hypoxia (MIH) as a preventive treatment for autonomic dysfunction in people with spinal cord injury. Participants will be exposed to MIH to see if it helps regulate blood pressure control and reduce complications related to sleep disordered breathing.See study design
What are the potential side effects?
Potential side effects may include discomfort from lack of oxygen (hypoxia), changes in heart rate or blood pressure during exposure sessions. However, specific side effects are not detailed here.
MIH and AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
I have a partial spinal cord injury above my chest.
MIH and AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 minutes, pre-intervention, 1 day after intervention, 2 weeks after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 minutes, pre-intervention, 1 day after intervention, 2 weeks after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Autonomic Dysreflexia
Secondary outcome measures
24-hour blood pressure variability
Orthostatic Hypotension
Spinal Cord Independence Measure (SCIM III)
Other outcome measures
Cardiac Function
Microvascular function
Mitochondrial Capacity
MIH and AD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mild Intermittent HypoxiaExperimental Treatment1 Intervention
This arm of the protocol will receive mild intermittent hypoxia (8% Oxygen) with end-tidal carbon dioxide maintained 1-3 millimeters of mercury above baseline, while in the laboratory. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.
Group II: ShamPlacebo Group1 Intervention
This arm of the protocol will receive sham air (21 % Oxygen) while in the laboratory. No additional gases will be employed. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.
Find a Location
Who is running the clinical trial?
John D. Dingell VA Medical CenterFED
8 Previous Clinical Trials
752 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,617 Previous Clinical Trials
3,315,909 Total Patients Enrolled
Gino Panza, PhDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience issues with involuntary body functions.I have a complete spinal cord injury.My spinal cord injury is below the middle of my back.I am between 18 and 60 years old.You work irregular hours that disrupt your sleep schedule.You smoke cigarettes.You have a problem with using drugs.I am either younger than 18 or older than 60.I have a partial spinal cord injury above my chest.I have open wounds or pressure sores on my skin.You have been injured for more than a year.I use insulin to manage my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Intermittent Hypoxia
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been accepted for this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that the study, which commenced on October 1st 2022 and has been edited as recently as October 21st 2022, is actively recruiting participants. 24 subjects are expected to be enrolled at two distinct centres of care."
Answered by AI
Is the age range for participants in this trial inclusive of those over 60?
"This clinical trial stipulates that the lower limit of eligibility is 18 years old, with an upper limit set at 60."
Answered by AI
Are there any vacancies left in this clinical research project?
"Confirmed. The information posted on clinicaltrials.gov states that this study, which was initially made available on October 1st 2022, is actively recruiting participants. 24 individuals must be enrolled from 2 distinct sites."
Answered by AI
Who meets the qualifications to participate in this clinical experimentation?
"This medical study is looking for 24 volunteers between the ages of 18 and 60, who have a diagnosis of autonomic dysreflexia. Those interested must also meet additional criteria: motor incomplete spinal cord injury at or above T6, evidence of autonomic dysfunction (measured by ADFSCI and ISAFSCI scores), as well as chronic injuries (> 1 year post-injury)."
Answered by AI
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