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Oxygen Toxicity: Mechanisms in Humans

Applied Physiology of Oxygen Toxicity: Mechanisms in Humans

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05761756
Enrollment
62
Registered
2023-03-09
Start date
2023-11-28
Completion date
2026-08-31
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnia, Oxygen Toxicity, Seizures

Brief 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.

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Equal numbers of male and female * Non-smokers * Aged 18-45 years * Males will be required to have VO2 peak \> or equal to mL/kg min * and females \> or equal to 30 mL/kg min

Exclusion criteria

* Pregnancy * Cardiorespiratory disease, including hypertension * Neuromuscular disease * Anemia * History of hemoglobinopathy, including sick cell disease and trait

Design outcomes

Primary

MeasureTime frame
Hypercapnic ventilatory response3 months

Secondary

MeasureTime frameDescription
Lactate, pyruvate3 months
Arterial PCO2Baseline and after Intervention/arm
Integrated diaphragmatic function (IDF) composite scoreBaseline and after Intervention/arm, which averages 3 monthsA composite score comprised of maximum breathing capacity (MBC), maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and diaphragmatic thickness will be used as the measure of Integrated diaphragmatic function (IDF).
Cerebral blood oxygenationBaseline and after Intervention/arm, which averages 3 months
Hormone levels (leptin, adiponectin)Baseline and after Intervention/arm, which averages 3 months

Countries

United States

Contacts

Primary ContactDerek B Covington, MD
derek.covington@duke.edu919-613-8881
Backup ContactRichard Moon, MD
Richard.moon@duke.edu919-613-8881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026