Hypobaric HypoxiaNCT04138446
Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
A study testing Altitude exposure in climate chamber in people with Hypobaric Hypoxia and Cognitive Deterioration, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypobaric Hypoxia, Cognitive Deterioration, Emergency Medicine
- What is being tested?
- Altitude exposure in climate chamber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2019to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Age 18-60 yr-old
- ASA class I
- Signed informed consent
Who cannot join
- Age <18 or >60 yr-old
- ASA class > I
- Informed consent not signed
Trial locations and contacts
1 site in 1 country.
Italy1 site
Eurac Research, Institute of Mountain Emergency Medicine
Bolzano, BZ, 39100
About this study
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.
Read more
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
- Hypobaric Hypoxia, Cognitive Deterioration, Emergency Medicine, Resuscitation, Stress Physiology
- Being tested
- Altitude exposure in climate chamber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 200-3000 | Experimental | Day 1: 200m (above sea level) asl Day 2: 3000m asl Receives: Other: Altitude exposure in climate chamber |
| 3000-200 | Experimental | Day 1: 3000m asl Day 2: 200m asl Receives: Other: Altitude exposure in climate chamber |
| 200-5000 | Experimental | Day 1: 200m asl Day 2: 5000m asl Receives: Other: Altitude exposure in climate chamber |
| 5000-200 | Experimental | Day 1: 5000m asl Day 2: 200m asl Receives: Other: Altitude exposure in climate chamber |
| 3000-5000 | Experimental | Day 1: 3000m asl Day 2: 5000m asl Receives: Other: Altitude exposure in climate chamber |
| 5000-3000 | Active comparator | Day 1: 5000m asl Day 2: 3000m asl Receives: Other: Altitude exposure in climate chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit-Symbol Substitution Task - DSST
Changes in working memory at altitude using a computer-based test (DSST)
Measured: 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)
Measured: 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)
Measured: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Secondary outcomes (6)
Digit-Symbol Substitution Task - DSST
Changes in working memory after exercise at altitude using a computer-based test (DSST)
Measured: 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
Changes in risk-taking behavior after exercise at altitude using a computer-based test (BART)
Measured: 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
Changes in reaction time after exercise at altitude using a computer-based test battery (PVT)
Measured: 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
Evaluation of the quality of chest compressions with a manikin and its electronic feedback device at different altitudes (200 meters vs. 3000 meters vs. 5000 meters)
Measured: Changes in 5 minute chest compressions
Reactive oxygen species - ROS
Changes in ROS in saliva samples (μmol/min)
Measured: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Total antioxidant capacity - TAC
Changes in TAC in saliva samples (mM)
Measured: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start25 Oct 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypobaric HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, University of Graz, Università degli Studi di Trento, Azienda Sanitaria dell'Alto Adige, Istituto di Fisiologia Clinica CNR
- Responsible party
- Principal investigator, Giacomo Strapazzon, MD PhD, Institute of Mountain Emergency Medicine
- Investigators
- Giacomo Strapazzon, MD PhD, Principal investigator, Eurac Research, Institute of Mountain Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138446
- Sponsor's protocol ID
- 3489044136
- Status last verified
- Mar 2020
- First submitted
- 18 Oct 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Publications
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.
PubMed 26779029Pietsch 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.
PubMed 30760298Li 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.
PubMed 11892743Bouak 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.
PubMed 29789086Basner 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.
PubMed 26564759Wang 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.
PubMed 25154345Vogele 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.
PubMed 34854317
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
- ClinicalTrials.gov ID
- NCT04138446
- Acronym / sponsor ID
- 3489044136
- Conditions
- Hypobaric Hypoxia, Cognitive Deterioration, Emergency Medicine, Resuscitation, Stress Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, University of Graz, Università degli Studi di Trento, Azienda Sanitaria dell'Alto Adige, Istituto di Fisiologia Clinica CNR
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
| Arm | Type | Receives |
|---|---|---|
| 200-3000 | Experimental | Other: Altitude exposure in climate chamberDay 1: 200m (above sea level) asl Day 2: 3000m asl |
| 3000-200 | Experimental | Other: Altitude exposure in climate chamberDay 1: 3000m asl Day 2: 200m asl |
| 200-5000 | Experimental | Other: Altitude exposure in climate chamberDay 1: 200m asl Day 2: 5000m asl |
| 5000-200 | Experimental | Other: Altitude exposure in climate chamberDay 1: 5000m asl Day 2: 200m asl |
| 3000-5000 | Experimental | Other: Altitude exposure in climate chamberDay 1: 3000m asl Day 2: 5000m asl |
| 5000-3000 | Active comparator | Other: Altitude exposure in climate chamberDay 1: 5000m asl Day 2: 3000m asl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age 18-60 yr-old
- ASA class I
- Signed informed consent
Key exclusion criteria (3 listed)
- Age <18 or >60 yr-old
- ASA class > I
- Informed consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altitude 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. | Other | 200-3000, 200-5000, 3000-200, 3000-5000, 5000-200, 5000-3000 |
Primary outcome
Digit-Symbol Substitution Task - DSST
Time frame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in working memory at altitude using a computer-based test (DSST)
Balloon Analog Risk Test - BART
Time frame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in risk-taking behavior at altitude using a computer-based test (BART)
Psychomotor Vigilance Test - PVT
Time frame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Changes in reaction time using a computer-based test (PVT)
6 secondary outcomes
Digit-Symbol Substitution Task - DSST
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Changes in 5 minute chest compressions
Reactive oxygen species - ROS
Time frame: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Total antioxidant capacity - TAC
Time frame: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 26779029Taylor 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.
- Background: PubMed 30760298Pietsch 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.
- Background: PubMed 11892743Li 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.
- Background: PubMed 29789086Bouak 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.
- Background: PubMed 26564759Basner 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.
- Background: PubMed 25154345Wang 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.
- Derived from this study: PubMed 34854317Vogele 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
Related trials for Hypobaric Hypoxia
Enrolling by invitationEarly Phase 1
Program Protocol for a Population That Works in Conditions of Hypobaric Hypoxia
Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions
Active, not recruitingPhase 4
Pharmacological Countermeasures for High Altitude
Hypobaric Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Strapazzon, MD PhD principal investigator
Eurac Research, Institute of Mountain Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altitude exposure in climate chamber in people with Hypobaric Hypoxia and Cognitive Deterioration, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit-Symbol Substitution Task - DSST (time frame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138446, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.