CompletedNCT05073406HEMS IIUpdated Mar 1, 2023

Cognition at Altitude in HEMS - Part II

An interventional study of Altitude exposure in hypobaric normoxic condition and Altitude exposure in hypobaric hypoxic condition in Hypobaric Hypoxia, Hypobaric Normoxia and Cognitive Performance, sponsored by Institute of Mountain Emergency Medicine. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Institute of Mountain Emergency Medicine · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones).

Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session.
In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.

Conditions studied

Hypobaric Hypoxia
Hypobaric Normoxia
Cognitive Performance
Emergency Medicine
Stress Physiology

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In context

Emergencies

1,691 studies on the registry are indexed under Emergencies; 332 are open to participants now.

This study's enrollment of 36 is below the median of 145 across 930 interventional studies indexed under Emergencies.

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Lead sponsor

Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

members of emergency medical services (EMS) and search and rescue (SAR) services with an occupational licence;
an age between 18 and 60 years;
an American Society of Anaesthesiologists (ASA) physical status class I;
provided informed and written consent;
no current COVID 19 symptoms and temperature ≤ 37.5°on test days, not being tested positive for COVID-19, ideally COVID-19 vaccinated.

Exclusion criteria

Exclusion Criteria:

members under the age of 18 years;
an ASA physical status class II or more;
a medical history of psychiatric disorders and neurological diseases;
previous high altitude pulmonary oedema (HAPE) or high altitude cerebral oedema (HACE) or severe acute mountain sickness (AMS) (defined as a Lake Louise Score (LLS) > 9) occurred at altitudes similar to the ones tested in the study;
no informed consent;
current COVID 19 symptoms, being tested positive for COVID-19 or symptoms and body temperature ≥ 37.5°on test days.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 36 participants (actual)

Study arms

Experimental
Hypobaric normoxia
Altitude exposure in hypobaric normoxic condition
Other: Altitude exposure in hypobaric normoxic condition
Sham comparator
Hypobaric hypoxia
Altitude exposure in hypobaric hypoxic condition
Other: Altitude exposure in hypobaric hypoxic condition

Interventions

OtherAltitude exposure in hypobaric normoxic condition
Altitude exposure with oxygen supplementation to achieve normoxia at altitude
OtherAltitude exposure in hypobaric hypoxic condition
Altitude exposure with air supplementation to obtain a sham comparator arm

What researchers measure

Primary outcomes

Psychomotor Vigilance Test - PVT
Changes in reaction time using a computer-based test (PVT)
Time frame: Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)
Digit-Symbol Substitution Task - DSST
Changing in processing speed using a computer based test (DSST)
Time frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
2-back Test
Changing in working memory using a computer based test (2-back test)
Time frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)

Study locations

1 site

Eurac Research, Institute of Mountain Emergency Medicine
Bolzano, BZ 39100, Italy

References and documents

Publications

Basner M, Moore TM, Nasrini J, Gur RC, Dinges DF. Standardization of psychomotor vigilance testing methods and reporting. Sleep. 2021 Jul 9;44(7):zsab114. doi: 10.1093/sleep/zsab114. No abstract available. PubMed 34019081 ↗
Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9. PubMed 29596018 ↗
Cable GG. In-flight hypoxia incidents in military aircraft: causes and implications for training. Aviat Space Environ Med. 2003 Feb;74(2):169-72. PubMed 12602449 ↗
EASA. https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-04. (2018).
Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021. PubMed 33995130 ↗
Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31. PubMed 35640630 ↗
Hart, S., and Staveland, L. (1988). "Development of NASA-TLX (task load index) - results ofempirical and theoretical research," in HumanMental Workload, eds P. Hancock and N. Meshkati (Amsterdam: Springer), 139-183. doi: 10.1016/ s0166- 4115(08)62386- 9.
Hinkelbein J, Glaser E. Evaluation of two oxygen face masks with special regard to inspiratory oxygen fraction (FiO2) for emergency use in rescue helicopters. Air Med J. 2008 Mar-Apr;27(2):86-90. doi: 10.1016/j.amj.2007.07.005. PubMed 18328973 ↗
Mrakic-Sposta S, Vezzoli A, Malacrida S, Falla M, Strapazzon G. "Direct" and "Indirect" Methods to Detect Oxidative Stress During Acute or Chronic High-Altitude Exposure. High Alt Med Biol. 2017 Sep;18(3):303-304. doi: 10.1089/ham.2017.0067. Epub 2017 Jul 28. No abstract available. PubMed 28753037 ↗
Nowacki J, Heekeren HR, Deuter CE, Joerissen JD, Schroder A, Otte C, Wingenfeld K. Decision making in response to physiological and combined physiological and psychosocial stress. Behav Neurosci. 2019 Feb;133(1):59-67. doi: 10.1037/bne0000288. Epub 2018 Dec 17. PubMed 30556701 ↗
Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6. PubMed 19161909 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05073406
Lead sponsor: Institute of Mountain Emergency Medicine
Collaborators: University Grenoble Alps, Università degli Studi di Trento, Medical University Innsbruck
Responsible party: Giacomo Strapazzon, MD PhD (Principal Investigator, Institute of Mountain Emergency Medicine) — Principal investigator
First posted: Oct 11, 2021
Start date: Sep 1, 2021
Primary completion: Dec 31, 2022
Completion: Dec 31, 2022
Last update: Mar 1, 2023

Study contacts

Giacomo Strapazzon, MD PhD

principal investigator · Eurac Research, Institute of Mountain Emergency Medicine

Marika Falla, MD PhD

principal investigator · University of Trento, Center for Mind/Brain Sciences - CIMeC

Michiel van Veelen, MD

principal investigator · Eurac Research, Institute of Mountain Emergency Medicine

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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