RecruitingNot ApplicableNCT05761756

Oxygen Toxicity: Mechanisms in Humans

Applied Physiology of Oxygen Toxicity: Mechanisms in Humans


Sponsor

Duke University

Enrollment

62 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the mechanisms of oxygen toxicity in scuba divers. The main questions it aims to answer are: * How does the training of respiratory muscles affect oxygen toxicity? * How do environmental factors, such as sleep deprivation, the ingestion of commonly utilized medications, and chronic exposure to carbon dioxide, impact the risk of oxygen toxicity? * How does immersion in water affect the development of oxygen toxicity? Participants will be asked to do the following: * Undergo a basic screening exam composed of health history, vital signs, and some respiratory function tests * Train their respiratory muscles at regular intervals * Exercise on a cycle ergometer both in dry conditions and underwater/under pressure in the context of medication, sleep deprivation, or carbon dioxide exposure Researchers will compare the performance of each subject before and after the possible interventions described above to see if there are changes in exercise performance, respiratory function, cerebral blood flow, and levels of gene expression.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the mechanisms of oxygen toxicity in healthy humans — specifically, what happens physiologically when people breathe very high concentrations of oxygen over time. While oxygen is life-giving at normal atmospheric concentrations, breathing pure or near-pure oxygen for extended periods can damage the lungs and other tissues. This is a real clinical concern for patients on mechanical ventilators or undergoing hyperbaric oxygen therapy, but the exact biological mechanisms in humans remain incompletely understood. To be eligible, you must be a non-smoking adult aged 18 to 45, with no cardiorespiratory disease, neuromuscular disease, anemia, or hemoglobin disorders (including sickle cell disease or trait). Males must have a VO2 peak (aerobic fitness measure) of at least 45 mL/kg/min, and females at least 30 mL/kg/min. Pregnancy is an exclusion criterion. The study aims to recruit equal numbers of men and women. Participants will breathe high-concentration oxygen under controlled conditions while researchers measure physiological responses including lung function, blood markers of oxidative stress, and cellular changes. This is foundational mechanistic research that could have significant implications for how intensivists and anesthesiologists set oxygen levels for critically ill and ventilated patients — a field where current evidence for safe oxygen limits remains surprisingly incomplete.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSleep Deprivation

24 hours sleep deprivation

DRUGCaffeine

Oral administration of caffeine

DRUGMethylphenidate

Oral administration of methylphenidate

DRUGCarbon Dioxide

Oral administration of sodium bicarbonate to simulate carbon dioxide exposure


Locations(1)

Duke University Health Sustem

Durham, North Carolina, United States

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NCT05761756


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