NCT05761756

Oxygen Toxicity: Mechanisms in Humans

Applied Physiology of Oxygen Toxicity: Mechanisms in Humans

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Oxygen Toxicity
• Hypercapnia
• Seizures

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2023-03-09
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States