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Altitude Diving for Decompression Sickness in Healthy People - Clinical Trial

What is the Purpose of this Study?

We are doing this study to improve the safety of diving underwater while at altitude (e.g., diving in a lake high in the mountains). 

What is the Condition Being Studied?

Decompression Sickness in Healthy People

Who Can Participate in the Study?

Adults age 18-40 who:
- Are generally healthy and physically fit
- Don't smoke
- Don't have heart or lung disease (including high blood pressure or airway obstruction),
- Don't have a seizure disorder, history of middle ear or sinus disease or high altitude cerebral or pulmonary edema (HACE, HAPE)
- Are unable to to perform middle ear autoinflation ('clear' your ears)
- Don't have anemia, sickle cell disease and sickle cell trait
- Aren't pregnant 

Age Group
Adults

What is Involved?

If you choose to be in the study you will:  

- Have a half-day screening visit including an exercise test to determine fitness  
- Spend 60 hours continuously in a hypobaric chamber at simulated altitudes of 10000 or 12000 ft
- Have blood and urine samples taken periodically throughout the altitude exposure  
- Complete questionnaires periodically to determine if there are any effects of altitude  
- Complete a 20 or 25 min dive to a depth of about 90 feet in warm water with light exercise with return to altitude  
- Have ultrasound testing after the dive to monitor if there are any effects of the dive  
- Be able to read and use an electronic device (tablets) during down-time        

Study Details

Full Title
Development of Decompression Tables for Diving at Altitude
Principal Investigator
Anesthesiologist
Protocol Number
IRB:PRO00087803
NCT:NCT03390335
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698