Neuroimaging During Pure Oxygen Breathing
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ClinicalTrials.gov Identifier: NCT03268590 |
Recruitment Status :
Completed
First Posted : August 31, 2017
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
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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:
- 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.
- Determine if changes that might occur in brain blood flow are also accompanied by changes in the brain's electrical activity (EEG).
- 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperoxia Hypoxia, Brain Neurobehavioral Manifestations | Drug: Oxygen | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All participants will undergo neuroimaging (MRI) with electroencephalographic (EEG) cortical network mapping and cognitive assessments during room air breathing (placebo). Room air (21% inspired oxygen) will be delivered via non-rebreather face mask. Persons will serve as their own control and will next undergo neuroimaging (MRI) with electroencephalographic (EEG) cortical network mapping and cognitive assessments during pure oxygen breathing. Pure oxygen (100% inspired oxygen) will be delivered via non-rebreather face mask |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Hyperoxia: An Unrecognized Mechanism for Inducing "Hypoxia-Like" Symptoms |
Actual Study Start Date : | October 2, 2017 |
Actual Primary Completion Date : | May 2, 2018 |
Actual Study Completion Date : | May 9, 2018 |

Arm | Intervention/treatment |
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Experimental: All Study Participants
Breathing 21% oxygen via non-rebreather face mask followed by breathing 100% oxygen via non-rebreather face mask
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Drug: Oxygen
Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will then breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls. |
- Cerebral Blood Flow [ Time Frame: Baseline and at 30 minutes ]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).
- Cortical Network Activity [ Time Frame: Baseline and at 30 minutes ]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).
- Cognitive Performance [ Time Frame: Baseline and at 30 minutes ]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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
- Height 152.5-195.5 cm, weight 40-135 kg.
Exclusion Criteria:
- 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.
- History of claustrophobia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268590
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Michael J Decker, PhD | Case Western Reserve University |
Documents provided by Michael J. Decker, Case Western Reserve University:
Responsible Party: | Michael J. Decker, Associate Professor, Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT03268590 |
Other Study ID Numbers: |
CON215044 FA8650-12-D6280 TO0052 ( Other Grant/Funding Number: KBRWyle (for Wright Patterson Air Force Base) ) |
First Posted: | August 31, 2017 Key Record Dates |
Results First Posted: | November 13, 2019 |
Last Update Posted: | November 13, 2019 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hyperoxia Hypoxia, Brain |
Neurobehavioral Manifestations Hypoxia, Brain Hypoxia Hyperoxia Signs and Symptoms, Respiratory |
Neurologic Manifestations Nervous System Diseases Brain Diseases Central Nervous System Diseases |