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
| Type | Name | Description |
|---|---|---|
| OTHER | Altitude exposure in climate chamber | Altitude 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.