Hyperoxia Clinical Trial
Official title:
Hyperoxia: An Unrecognized Mechanism for Inducing "Hypoxia-Like" Symptoms
Verified date | October 2019 |
Source | Case Western Reserve University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct a non-randomized clinical trial to examine the effect of pure
oxygen breathing on the brain. The study will compare cerebral blood flow, cortical
electrical activity, and cognitive performance in 32 persons during room air (21% oxygen)
breathing and pure oxygen (100% oxygen) breathing. Subjects will be used as their own
controls. The investigators aim to:
1. Determine whether breathing 100% oxygen changes blood flow through the brain. The
investigators will learn whether brain blood flow is increased, decreased or stays the
same.
2. Determine if changes that might occur in brain blood flow are also accompanied by
changes in the brain's electrical activity (EEG).
3. Learn whether changes in the speed at which the brain processes information (cognitive
function) accompany changes in brain blood flow and electrical activity that may be
seen.
Status | Completed |
Enrollment | 33 |
Est. completion date | May 9, 2018 |
Est. primary completion date | May 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Persons recruited from currently approved Human Subject Panel for high altitude studies at Wright Patterson Air Force Base, Dayton, OH. Volunteers will have documentation of past exposure to hypobaric conditions, either from past high-altitude flight, as hypobaric chamber personnel, or as participants in previous/current high altitude studies. Persons without past exposure to hypobaric conditions were also eligible to participate. 2. Height 152.5-195.5 cm, weight 40-135 kg. Exclusion Criteria: 1. Persons who have contraindications to MRI such as cardiac pacemakers, intracranial aneurysm clips, metallic implants or external clips within 10 mm of the head; implanted metallic devices such as pumps or previously implanted neurostimulation devices; cochlear implants, defibrillators, pacing wires, body piercings that cannot be removed, metal filings such as shrapnel, tattoos on the head and neck, or medical conditions contraindicated for MRI safety. 2. History of claustrophobia |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral Blood Flow | Change in brain blood flow from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using Magnetic Resonance Imaging (MRI). | Baseline and at 30 minutes | |
Secondary | Cortical Network Activity | Change in alpha cortical electrical activity in the temporal brain region from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using MRI-compatible 64-electrode high-density electroencephalography (EEG). | Baseline and at 30 minutes | |
Secondary | Cognitive Performance | Change in cognitive performance from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using the General Cognitive Function score on the MicroCog^TM Assessment of Cognitive Functioning (TM= trademark of Pearson Education, Inc., New York, NY). The computer-administered MicroCog measures changes in cognitive performance in 9 domains related to attention, memory, reasoning, spatial processing, and reaction time. The General Cognitive Function score is a summed score and measures accuracy and speed processing. Education-adjusted Standardized Scores used to compare each study participant against population norms. Higher scores are indicative of better performance. Index Standardized Scores of 69 and below are considered Below Average; scores of 70-84 are considered Low Average; scores of 85-114 are considered to be Average; and scores of 115 and above are considered to be Above Average. | Baseline and at 30 minutes |
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