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Oxygen Toxicity: Mechanisms in Humans

NCT05761756 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-10-23

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Sleep Deprivation

24 hours sleep deprivation

DRUG

Caffeine

Oral administration of caffeine

DRUG

Methylphenidate

Oral administration of methylphenidate

DRUG

Carbon Dioxide

Oral administration of sodium bicarbonate to simulate carbon dioxide exposure

Sponsors & Collaborators

Principal Investigators

  • Derek B Covington, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761756 on ClinicalTrials.gov