Clinical Trials Directory

Trials / Completed

CompletedNCT04138446

Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Institute of Mountain Emergency Medicine · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level). Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation. On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure. During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages: * a basal cognitive test battery * blind ascent in the hypobaric chamber to simulated altitude * cognitive test battery * 5 minutes of recorded chest compressions on dummies * cognitive test battery * blind descent in the hypobaric chamber. During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device. Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.

Conditions

Interventions

TypeNameDescription
OTHERAltitude exposure in climate chamberAltitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl.

Timeline

Start date
2019-10-25
Primary completion
2019-11-11
Completion
2019-11-11
First posted
2019-10-24
Last updated
2020-03-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04138446. Inclusion in this directory is not an endorsement.