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Carbon Dioxide Exposure for Seizures

N/A

Recruiting

Led By Derek B Covington, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Equal numbers of male and female

Aged 18-45 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial wants to understand how oxygen toxicity affects scuba divers. They want to find out how different factors like training of respiratory muscles, environmental conditions, and immersion in water affect the risk of oxygen toxicity

Who is the study for?

This trial is for non-smoking men and women aged 18-45 who are in good health with a specific level of cardiovascular fitness (VO2 peak). It's designed to understand oxygen toxicity in scuba divers, focusing on how respiratory training, environmental factors like sleep deprivation and CO2 exposure, affect the risk.Check my eligibility

What is being tested?

The study tests the effects of carbon dioxide, caffeine, sleep deprivation, and methylphenidate on oxygen toxicity. Participants will undergo respiratory muscle training and exercise tests both dry and underwater to measure changes in performance, lung function, brain blood flow, and gene expression.See study design

What are the potential side effects?

Potential side effects may include discomfort from respiratory exercises or cycle ergometer use. Exposure to high oxygen levels can lead to seizures or lung irritation. Caffeine might cause jitteriness or heart palpitations; methylphenidate could have similar stimulant effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My gender has been considered for the study's balance.

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I am between 18 and 45 years old.

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My peak oxygen intake meets the required level.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hypercapnic ventilatory response

Secondary outcome measures

Arterial PCO2

Cerebral blood oxygenation

Hormone levels (leptin, adiponectin)

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: MethylphenidateExperimental Treatment1 Intervention

Effect of caffeine and methylphenidate on HCVR and arterial PCO2 during submersed rest and exercise at 98 fsw. Twenty subjects will be similarly sleep-deprived, tested as above and then re-tested tested following oral administration of administration of either oral caffeine (N=10) or methylphenidate (N=10). Pre-dive caffeine will be administered 500 mg orally [59]. Pre-dive methylphenidate will be administered as a single dose of 5 mg [60]. The order of drug administration vs. control will be randomized. Measurements at 98 fsw will be obtained at rest and during 10 minutes of moderate exercise in thermoneutral (29-30°C) water. fNIRS will be used to assess cerebral oxygenation and regional blood volume.

Group II: Carbon Dioxide ExposureExperimental Treatment1 Intervention

Effect of simulated chronic CO2 exposure on HCVR and arterial PCO2 during submersed rest and exercise at 98 fsw. Ten subjects will be studied before and after induction of metabolic alkalosis as described above with daily oral administration of sodium bicarbonate. Oral bicarbonate to simulate hypercapnia exposure will seek to increase serum bicarbonate to 30 mM/L via daily oral intake of 6 teaspoons of NaHCO3 for five days. Subsequently, blood will be drawn and intake adjusted as necessary [61]. The order of alkalization vs. control will be randomized. Measurements at 98 fsw will be obtained at rest and during 10 minutes of moderate exercise in thermoneutral (29-30°C) water.

Group III: CaffeineExperimental Treatment1 Intervention

Group IV: Sleep DeprivationActive Control1 Intervention

Effect of sleep deprivation on HCVR and arterial PCO2 during submersed rest and exercise at 98 fsw. Ten subjects will be tested before and after 24 hours of sleep deprivation. The order of sleep deprivation vs. control will be randomized. Measurements at 98 fsw will be obtained at rest and during 10 minutes of moderate exercise in thermoneutral (29-30°C) water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

Carbon Dioxide

2013

Completed Phase 2

~500

Caffeine

2014

Completed Phase 3

~2980

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,365 Previous Clinical Trials

3,420,578 Total Patients Enrolled

12 Trials studying Seizures

36,202 Patients Enrolled for Seizures

Derek B Covington, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 30 eligible to participate in this study?

"To be eligible for this clinical trial, potential participants must fall within the age range of 18 to 45 years old."

Answered by AI

Is the enrollment for this medical study currently accepting new participants?

"Indeed, according to the details provided on clinicaltrials.gov, this trial is currently accepting patients. The initial posting of the study was made on November 28th, 2023, and it was last updated on January 19th, 2024."

Answered by AI

How large is the participant pool for this particular medical study?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is actively seeking eligible individuals. The initial posting date of the clinical trial was November 28th, 2023 and it underwent its most recent update on January 19th, 2024. A total of 62 participants will be enrolled at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxygen Toxicity: Mechanisms in Humans

2023. "Oxygen Toxicity: Mechanisms in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761756.

All > Toxicity