NCT04138446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

17 days

First QC Date

October 18, 2019

Last Update Submit

March 23, 2020

Conditions

Hypobaric HypoxiaCognitive DeteriorationEmergency MedicineResuscitationStress Physiology

Outcome Measures

Primary Outcomes (3)

  • Digit-Symbol Substitution Task - DSST

    Changes in working memory at altitude using a computer-based test (DSST)

    Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)

  • Balloon Analog Risk Test - BART

    Changes in risk-taking behavior at altitude using a computer-based test (BART)

    Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)

  • Psychomotor Vigilance Test - PVT

    Changes in reaction time using a computer-based test (PVT)

    Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)

Secondary Outcomes (6)

  • Digit-Symbol Substitution Task - DSST

    Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)

  • Balloon Analog Risk Test - BART

    Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)

  • Psychomotor Vigilance Test - PVT

    Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)

  • Proportion of correct chest compressions regarding depth, pressure point and pressure release

    Changes in 5 minute chest compressions

  • Reactive oxygen species - ROS

    Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)

  • +1 more secondary outcomes

Study Arms (6)

200-3000

EXPERIMENTAL

Day 1: 200m (above sea level) asl Day 2: 3000m asl

Other: Altitude exposure in climate chamber

3000-200

EXPERIMENTAL

Day 1: 3000m asl Day 2: 200m asl

Other: Altitude exposure in climate chamber

200-5000

EXPERIMENTAL

Day 1: 200m asl Day 2: 5000m asl

Other: Altitude exposure in climate chamber

5000-200

EXPERIMENTAL

Day 1: 5000m asl Day 2: 200m asl

Other: Altitude exposure in climate chamber

3000-5000

EXPERIMENTAL

Day 1: 3000m asl Day 2: 5000m asl

Other: Altitude exposure in climate chamber

5000-3000

ACTIVE COMPARATOR

Day 1: 5000m asl Day 2: 3000m asl

Other: Altitude exposure in climate chamber

Interventions

Altitude exposure in climate chamberOTHER

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

200-3000200-50003000-2003000-50005000-2005000-3000

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Age 18-60 yr-old
  • ASA class I
  • Signed informed consent

You may not qualify if:

  • Age \<18 or \>60 yr-old
  • ASA class \> I
  • Informed consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurac Research, Institute of Mountain Emergency Medicine

Bolzano, BZ, 39100, Italy

Location

Related Publications (7)

  • Taylor L, Watkins SL, Marshall H, Dascombe BJ, Foster J. The Impact of Different Environmental Conditions on Cognitive Function: A Focused Review. Front Physiol. 2016 Jan 6;6:372. doi: 10.3389/fphys.2015.00372. eCollection 2015.

    PMID: 26779029BACKGROUND

  • Pietsch U, Strapazzon G, Ambuhl D, Lischke V, Rauch S, Knapp J. Challenges of helicopter mountain rescue missions by human external cargo: need for physicians onsite and comprehensive training. Scand J Trauma Resusc Emerg Med. 2019 Feb 13;27(1):17. doi: 10.1186/s13049-019-0598-2.

    PMID: 30760298BACKGROUND

  • Li XY, Wu XY, Fu C, Shen XF, Yang CB, Wu YH. Effects of acute exposure to mild or moderate hypoxia on human psychomotor performance and visual-reaction time. Space Med Med Eng (Beijing). 2000 Aug;13(4):235-9.

    PMID: 11892743BACKGROUND

  • Bouak F, Vartanian O, Hofer K, Cheung B. Acute Mild Hypoxic Hypoxia Effects on Cognitive and Simulated Aircraft Pilot Performance. Aerosp Med Hum Perform. 2018 Jun 1;89(6):526-535. doi: 10.3357/AMHP.5022.2018.

    PMID: 29789086BACKGROUND

  • Basner M, Savitt A, Moore TM, Port AM, McGuire S, Ecker AJ, Nasrini J, Mollicone DJ, Mott CM, McCann T, Dinges DF, Gur RC. Development and Validation of the Cognition Test Battery for Spaceflight. Aerosp Med Hum Perform. 2015 Nov;86(11):942-52. doi: 10.3357/AMHP.4343.2015.

    PMID: 26564759BACKGROUND

  • Wang JC, Tsai SH, Chen YL, Hsu CW, Lai KC, Liao WI, Li LY, Kao WF, Fan JS, Chen YH. The physiological effects and quality of chest compressions during CPR at sea level and high altitude. Am J Emerg Med. 2014 Oct;32(10):1183-8. doi: 10.1016/j.ajem.2014.07.007. Epub 2014 Jul 30.

    PMID: 25154345BACKGROUND

  • Vogele A, van Veelen MJ, Dal Cappello T, Falla M, Nicoletto G, Dejaco A, Palma M, Hufner K, Brugger H, Strapazzon G. Effect of Acute Exposure to Altitude on the Quality of Chest Compression-Only Cardiopulmonary Resuscitation in Helicopter Emergency Medical Services Personnel: A Randomized, Controlled, Single-Blind Crossover Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e021090. doi: 10.1161/JAHA.121.021090. Epub 2021 Dec 2.

    PMID: 34854317DERIVED

Study Officials

  • Giacomo Strapazzon, MD PhD

    Eurac Research, Institute of Mountain Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 24, 2019

Study Start

October 25, 2019

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months from study completion
Access Criteria
Access will be granted to primary collaborators who will be required to sign a Data Access agreement

Locations

IT(1)