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NCT Number: NCT05761756

Oxygen Toxicity: Mechanisms in Humans

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health Sustem

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Derek Covington, M.D.

CONTACT

[email protected]

919-613-8881

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep deprivation

Behavioral

24 hours sleep deprivation

Caffeine

Drug

Oral administration of caffeine

Methylphenidate

Drug

Oral administration of methylphenidate

Carbon Dioxide

Drug

Oral administration of sodium bicarbonate to simulate carbon dioxide exposure

Primary outcomes

  1. Hypercapnic ventilatory response

    Time frame: 3 months

Secondary outcomes

  1. Lactate, pyruvate

    Time frame: 3 months

  2. Arterial PCO2

    Time frame: Baseline and after Intervention/arm

  3. Integrated diaphragmatic function (IDF) composite score

    Time frame: Baseline and after Intervention/arm, which averages 3 months

    A 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).

  4. Cerebral blood oxygenation

    Time frame: Baseline and after Intervention/arm, which averages 3 months

  5. Hormone levels (leptin, adiponectin)

    Time frame: Baseline and after Intervention/arm, which averages 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Derek B Covington, MD

CONTACT

[email protected]

919-613-8881

Richard Moon, MD

CONTACT

[email protected]

919-613-8881

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Applied Physiology of Oxygen Toxicity: Mechanisms in Humans

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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