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Oxygen Toxicity: Mechanisms in Humans

ConditionsOxygen ToxicityHypercapniaSeizures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDuke University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Cardiorespiratory disease, including hypertension

Neuromuscular disease

Anemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

62 Participants
are divided into 4 treatment groups
Group A: Sleep DeprivationActive comparator 1 intervention
Group B: CaffeineExperimental treatment 1 intervention
Group C: MethylphenidateExperimental treatment 1 intervention
Group D: Carbon Dioxide ExposureExperimental treatment 1 intervention

Trial outcomes

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

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).

Time frame
Baseline and after Intervention/arm, which averages 3 months
4

Cerebral blood oxygenation

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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