CNS Ox Tox: Mechanisms (Diving Study for Healthy Volunteers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how certain breathing exercises can affect people's ability to swim and exercise in underwater conditions. We want to find out what effects this training has and how it is influenced by other factors, like water temperature, medication use, or sleep.

What is the Condition Being Studied?

The Effect of Exercise, Sleep, and Other Factors on Diving Ability

Who Can Participate in the Study?

Adults ages 18-45 who:

  • Are in good general health
  • Do not smoke
  • Do not have any history of blood disorders or cardiovascular disease (includes hypertension)

For more information about who can join this study, contact the study team at 919-684-6726.

Age Group
Adults

What is Involved?

If you choose to join this study, you will visit our clinic at the Center for Hyperbaric Medicine and Environmental Physiology for a screening visit to find out if you are eligible.

During this visit, you will:

  • Have a physical exam
  • Have an electrocardiogram
  • Do a series of breathing tests
  • Do a strenuous exercise test on a stationary bike to calculate your fitness level (VO2 max test)

If you are eligible, you will return to our clinic to do an underwater exercise test. This test is done in a tank of water inside a hyperbaric chamber that will mimic the conditions of being 98 feet beneath the surface of the ocean. Before you begin the test, we will place a catheter (a thin, flexible tube) into a vein in your arm to take blood samples during the test. You will exercise underwater for about 10 minutes while being closely watched to ensure your safety.

After this test is done, you will get a random assignment (like a coin flip) to 1 of 2 groups. You may get an assignment to:

  • Do a 4-week exercise program to train your breathing muscles; OR
  • Not do any training focused on your breathing muscles

If you are assigned to the training program arm of the study, you will do the exercises 5 days per week for about 30 minutes each time.

About a month after your first underwater exercise test, you will return to our clinic for a second test. During this second test, 1 of the 4 following changes will be made from the first test:

  • You may be assigned to do the test after you have gone 24 hours without sleeping; OR
  • You may be assigned to do the test after you have gone 24 hours without sleeping and taken a stimulant medication (caffeine or methylphenidate); OR
  • You may be assigned to do the test while being exposed to both warm and cold water (around 66-68 degrees fahrenheit); OR
  • You may be assigned to do the test while being exposed to elevated levels of carbon dioxide

If you are assigned to one of the sleep deprivation groups, we will provide lodging for you overnight to make sure you don't go to sleep and give you a ride to the clinic and back to your home.

Study Details

Full Title
Applied Physiology of CNS Oxygen Toxicity: Mechanisms in Humans
Principal Investigator
Protocol Number
IRB: PRO00112396
NCT: NCT05761756
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment