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All Study Participants for Hyperoxia Response

Phase 4
Waitlist Available
Led By Michael J Decker, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 30 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Hyperoxia Response
  • Cognitive Symptoms
  • Anoxic Encephalopathy
  • Neurobehavioral Symptoms
  • Hyperoxia
  • Brain Hypoxia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cerebral Blood Flow
Secondary study objectives
Cognitive Performance
Cortical Network Activity

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All Study ParticipantsExperimental Treatment1 Intervention
Breathing 21% oxygen via non-rebreather face mask followed by breathing 100% oxygen via non-rebreather face mask
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen
FDA approved

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
308 Previous Clinical Trials
250,680 Total Patients Enrolled
Michael J Decker, PhDPrincipal InvestigatorCase Western Reserve University
1 Previous Clinical Trials
21 Total Patients Enrolled
~4 spots leftby Nov 2025
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