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Acute Intermittent Hypoxia for Traumatic Brain Injury (AIH Trial)
AIH Trial Summary
This trial is studying whether it is safe for people with TBI to have their oxygen levels reduced briefly and if doing so has any effect on memory, cognition, and motor control.
- Traumatic Brain Injury
AIH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAIH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AIH Trial Design
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Who is running the clinical trial?
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- You already have a lung condition that causes low oxygen levels.You have a history of serious breathing problems like COPD or asthma.Your Glasgow Coma Scale score, which measures your level of consciousness, should be between 9 and 15.You are not currently participating in any other study that involves testing how your brain and behavior work.You have been diagnosed with a major mental illness like psychosis or have a significant learning disability since childhood.
- Group 1: AIH group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the ambition of this research endeavor?
"The primary metric of this 30-minute hypoxia session is a change in verbal response to a 10-Item Subjective Symptom Checklist. Secondary outcomes include an alteration in intracortical inhibition, measured through Transcranial magnetic stimulation (TMS), and modifications in Visual Analogue Mood Scale (VAM-S) score and California Verbal Learning Test (CVLT) score."
How many participants is the research team recruiting to take part in this clinical trial?
"Affirmative, clinicaltrials.gov substantiates that this study is presently recruiting participants. It was first made available on March 15th 2022 and the information was last refreshed on May 10th of the same year. The trial necessitates 16 individuals to be enrolled at a single location."
Do I meet the qualifications necessary to participate in this experiment?
"This medical trial is currently seeking 16 participants that have experienced a mild to moderate TBI, ranging in age from 18 to 65. In order for applicants to be accepted into the study they must fulfill additional criteria such as possessing the ability to use a keyboard and communicate fluently in English, being able confirm negative pregnancy status (if applicable), not engaging with any other research initiatives concerning neurobehavioral functioning, and having an available Glasgow Coma Scale score between 9-15."
Is there an age restriction for inclusion in this clinical investigation?
"This survey is open to patients aged 18-65. There are additional studies available for those under 18 (190) and over 65 (798)."
Is recruitment for this clinical trial still available?
"Affirmative, the information on clinicaltrials.gov indicates that this medical study is presently recruiting patients. Originally posted in mid-March of 2022, with a most recent update from early May 2021; the research team are actively seeking 16 individuals to take part at one site."
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