Oxygen Toxicity: Mechanisms in Humans

StatusSuspended
PhaseNot applicable
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Pending-funding Show 6 more changesShow less
    • Primary and study completion pushed from Aug 31, 2026 to Jan 31, 2027
    • Interventions modified
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised
    • Publications: details revised at 14 of 14 entries
  2. Primary and study completion dates: Mar 2026 to Aug 31, 2026v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2024 to Nov 28, 2023
    v3
  5. Start date: Aug 2023 to Feb 2024
    • Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 5 entries
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duke University
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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.
Trial Details
NCT Number NCT05761756
Lead Sponsor Duke University
Conditions
(from sponsor)		 Oxygen Toxicity, Hypercapnia, Seizures
Related terms Hypercapnia, Seizures
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov