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The Psychophysiological Effect of Simulated and Terrestrial Altitude (Hypoxia)

Primary Purpose

Hypoxia, Altitude Hypoxia, Altitude Sickness

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Terrestrial altitude
Cloud 9
Sponsored by
University of Applied Sciences and Arts of Southern Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia focused on measuring hypoxia, altitude, physiology, cognition

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, adults aged 18 to 50 years
  • No cardiovascular disease and / or surgery
  • no surgery on the cardiovascular system.
  • No current injuries and / or pain
  • Regular and adequate sleep
  • No terrestrial altitude of 1000 m exceeded last month (including flights)
  • No form of hypoxia exposed last month

Exclusion Criteria:

  • Age over 50 years
  • current injuries of any kind and / or pain
  • Acute and / or chronic pain conditions Known general diseases (e.g., diabetes mellitus)
  • fear of hypoxia
  • fear of heights or sensitivity to terrestrial altitude
  • Regular use of medicines (also bought by yourself), except for contraceptives
  • Cardiovascular diseases or abnormalities
  • Anomalies of the blood analysis or ECG
  • Psychological disorders
  • pregnancy / lactation

Sites / Locations

  • Fachhochschule SüdschweizRecruiting
  • Fachhochschule SüdschweizRecruiting
  • Fachhochschule SüdschweizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Simulated altitude

Terrestrial altitude

Control

Arm Description

The participants are exposed to simulated altitude in a normobaric situation.

The participants are exposed to terrestrial altitude in a hypobaric situation.

the participants are exposed to a normoxic and normobaric environment.

Outcomes

Primary Outcome Measures

Perfusion of the skin microcirculation
Perfusion of skin microcirculation is demonstrated non-invasively using the Laser Speckle Contrast Imager (moorFLPI 2, moor instruments, www.moor.co.uk). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the perfusion of the skins' microcirculation.
Oxygenation of the muscles and the brain
Muscle and brain oxygen saturation is measured non-invasively using a deep tissue oxygenation monitor (moorVMS-NIRS, moor instruments, www.moor.co.uk). For this purpose, adhesive electrodes are applied over the muscle and the forehead. This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the muscles and the brain.
Oxygenation of the blood
The oxygen saturation of the blood is measured with a portable pulse oximeter with finger clip probe (Nonin 7500, Nonin medical B.V., Plymouth, USA). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the blood.
Blood pressure
Blood pressure (systolic and diastolic) is detected by an electronically automated upper arm blood pressure monitor (Boso-Medicus uno). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the blood pressure.
Heart rate
The heart rate is measured using a pulse belt and an additional 2-point ECG (Actiheart, Camntech Ltd., Cambridge, UK). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the heart rate.
Skin temperature
Skin temperature is measured using the iButton system (www.ibuttonlink.com). The self-adhesive sensors wirelessly transmit skin temperature information to a computer. Furthermore, the skin temperature is recorded by means of a thermal imaging camera (FLIR). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the skin temperature.
Concentration of blood lactate and creatine kinase
Lactate and creatine kinase measurements are performed by capillary blood measurement (Accutrend, Roche Diagnostic, Red Cross, Switzerland & Reflotron, Roche Diagnostic, Rotkreuz, Switzerland). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for lactate and creatine kinase.
Balance
The fluctuations of the hull are recorded and evaluated with the Sway Star Systems (www.b2i.info). The Sway Star is a measuring instrument that contains gyroscopes. It is attached to a strap which is applied around the waist of the patient. The data is evaluated with the associated Sway Star software and transferred to the data sheet. This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for balance.
Pain threshold: pain pressure gauge
The pain threshold is measured by means of a pain pressure gauge (NOD, www.to-nod.com). This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for pain threshold.
Sleep disorder
Sleep disorder is measured with "Standford sleepiness scale", choosing one answer from seven (1=no sleepiness, 7=extreme sleepiness). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Altitude sickness
Altitude sickness is measured with "Lake Louis acute mountain sickness scale", choosing the most appropriate answer from 5 questions. Questions range from 0 (=no symptoms) to 4 (=severe symptoms).The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Dyspnoea
Dyspnoea is measured with the "modified BORG scale", choosing a number from 0 (=no dyspnoea) to 10 (=maximum dyspnoea). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Mental state
Mental state is assessed using "profile of the mood state", answering 37questions. Each question has a score from 0 (=not at all) to 4 (=extremely). The total sum of the scores is used. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Cognition
Cognitive tests consists of 8 tasks (automated neuropsychological assessment metrics). Lower values are better than higher values and are analyzed individually. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.

Secondary Outcome Measures

Thermal comfort and sensation
These parameters are measured by a thermal comfort scale (ranging from 0 [comfortable] to +4 [very uncomfortable]) and a thermal sensation scale (ranging from -4 [ver cold] to +4 [very hot]). These measurements are performed after the baseline measurement and after the cold water bath immersion of the hand and report the change from baseline.

Full Information

First Posted
August 7, 2019
Last Updated
May 11, 2021
Sponsor
University of Applied Sciences and Arts of Southern Switzerland
Collaborators
University of Portsmouth, Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04075565
Brief Title
The Psychophysiological Effect of Simulated and Terrestrial Altitude
Acronym
Hypoxia
Official Title
The Psychophysiological Effect of Simulated and Terrestrial Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Applied Sciences and Arts of Southern Switzerland
Collaborators
University of Portsmouth, Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the psychophysiological effects of terrestrial altitude with a normobaric, hypoxic situation.
Detailed Description
Research has consistently shown that exposure to extreme environments (such as high altitude stays) may affect cognitive function. For logistical reasons and to control the experimental set-ups, most of these examinations are carried out in the laboratory. By testing under such controlled conditions, researchers can remove any co-foundational factors and isolate the cause of stress, thereby better understanding the mechanisms by which impairment can occur. However, when people are exposed to such environments in the "real world" (such as altitude), they often experience a number of other additional stressors at the same time, which can also affect their performance. Surprisingly, however, little attention has been paid to the study of these additional stressors in combination. Although the oxygen content remains constant at various altitudes (20.93%), the air pressure decreases exponentially as the altitude increases. As a result, the oxygen partial pressure in arterial blood and tissue is reduced (hypoxia), leading to a deterioration in both physical and cognitive performance. Hypoxic conditions also alter the perception of pain, which may be particularly relevant for patients suffering from hypoxic conditions. According to the authors' knowledge, there is limited literature investigating and comparing simulated and real psychophysiological responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude Hypoxia, Altitude Sickness, Altitude, Mountain Sickness, Hypoxia, Altitude
Keywords
hypoxia, altitude, physiology, cognition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study design is a crossover design.
Masking
Investigator
Allocation
Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simulated altitude
Arm Type
Active Comparator
Arm Description
The participants are exposed to simulated altitude in a normobaric situation.
Arm Title
Terrestrial altitude
Arm Type
Experimental
Arm Description
The participants are exposed to terrestrial altitude in a hypobaric situation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
the participants are exposed to a normoxic and normobaric environment.
Intervention Type
Behavioral
Intervention Name(s)
Terrestrial altitude
Intervention Description
Terrestrial altitude: The volunteers are in an SAC hut at an altitude of 3000 m. By means of this exposure the psychophysiological effect under hypobaric and hypoxic conditions is determined. The subjects spend the night in this SAC hut and the measurements are repeated the next day.
Intervention Type
Behavioral
Intervention Name(s)
Cloud 9
Intervention Description
Cloud 9 is a solid, certified product that complies with European Directives on Electromagnetic Compatibility, Machine Directive, Air Pressure Equipment and Low Voltage Equipment (89/336 / EEC, 91/368 / CEE, 93/68 / CEE, 97/23 / EC, EN61010-1 All directives are in writing in the Supplements to this Ethics Application. Simulated height: The subjects are in the laboratory of our institution and are connected to the Cloud 9 by means of a mask. Subjects are exposed to a simulated altitude of 3530m under normobaric conditions. By means of this intervention the psychophysiological effect under normobaric and hypoxic conditions is determined.
Primary Outcome Measure Information:
Title
Perfusion of the skin microcirculation
Description
Perfusion of skin microcirculation is demonstrated non-invasively using the Laser Speckle Contrast Imager (moorFLPI 2, moor instruments, www.moor.co.uk). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the perfusion of the skins' microcirculation.
Time Frame
30 minutes
Title
Oxygenation of the muscles and the brain
Description
Muscle and brain oxygen saturation is measured non-invasively using a deep tissue oxygenation monitor (moorVMS-NIRS, moor instruments, www.moor.co.uk). For this purpose, adhesive electrodes are applied over the muscle and the forehead. This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the muscles and the brain.
Time Frame
30 minutes
Title
Oxygenation of the blood
Description
The oxygen saturation of the blood is measured with a portable pulse oximeter with finger clip probe (Nonin 7500, Nonin medical B.V., Plymouth, USA). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the blood.
Time Frame
30 minutes
Title
Blood pressure
Description
Blood pressure (systolic and diastolic) is detected by an electronically automated upper arm blood pressure monitor (Boso-Medicus uno). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the blood pressure.
Time Frame
30 minutes
Title
Heart rate
Description
The heart rate is measured using a pulse belt and an additional 2-point ECG (Actiheart, Camntech Ltd., Cambridge, UK). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the heart rate.
Time Frame
30 minutes
Title
Skin temperature
Description
Skin temperature is measured using the iButton system (www.ibuttonlink.com). The self-adhesive sensors wirelessly transmit skin temperature information to a computer. Furthermore, the skin temperature is recorded by means of a thermal imaging camera (FLIR). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the skin temperature.
Time Frame
30 minutes
Title
Concentration of blood lactate and creatine kinase
Description
Lactate and creatine kinase measurements are performed by capillary blood measurement (Accutrend, Roche Diagnostic, Red Cross, Switzerland & Reflotron, Roche Diagnostic, Rotkreuz, Switzerland). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for lactate and creatine kinase.
Time Frame
30 minutes
Title
Balance
Description
The fluctuations of the hull are recorded and evaluated with the Sway Star Systems (www.b2i.info). The Sway Star is a measuring instrument that contains gyroscopes. It is attached to a strap which is applied around the waist of the patient. The data is evaluated with the associated Sway Star software and transferred to the data sheet. This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for balance.
Time Frame
30 minutes
Title
Pain threshold: pain pressure gauge
Description
The pain threshold is measured by means of a pain pressure gauge (NOD, www.to-nod.com). This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for pain threshold.
Time Frame
30 minutes
Title
Sleep disorder
Description
Sleep disorder is measured with "Standford sleepiness scale", choosing one answer from seven (1=no sleepiness, 7=extreme sleepiness). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes
Title
Altitude sickness
Description
Altitude sickness is measured with "Lake Louis acute mountain sickness scale", choosing the most appropriate answer from 5 questions. Questions range from 0 (=no symptoms) to 4 (=severe symptoms).The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes
Title
Dyspnoea
Description
Dyspnoea is measured with the "modified BORG scale", choosing a number from 0 (=no dyspnoea) to 10 (=maximum dyspnoea). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes
Title
Mental state
Description
Mental state is assessed using "profile of the mood state", answering 37questions. Each question has a score from 0 (=not at all) to 4 (=extremely). The total sum of the scores is used. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes
Title
Cognition
Description
Cognitive tests consists of 8 tasks (automated neuropsychological assessment metrics). Lower values are better than higher values and are analyzed individually. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Thermal comfort and sensation
Description
These parameters are measured by a thermal comfort scale (ranging from 0 [comfortable] to +4 [very uncomfortable]) and a thermal sensation scale (ranging from -4 [ver cold] to +4 [very hot]). These measurements are performed after the baseline measurement and after the cold water bath immersion of the hand and report the change from baseline.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, adults aged 18 to 50 years No cardiovascular disease and / or surgery no surgery on the cardiovascular system. No current injuries and / or pain Regular and adequate sleep No terrestrial altitude of 1000 m exceeded last month (including flights) No form of hypoxia exposed last month Exclusion Criteria: Age over 50 years current injuries of any kind and / or pain Acute and / or chronic pain conditions Known general diseases (e.g., diabetes mellitus) fear of hypoxia fear of heights or sensitivity to terrestrial altitude Regular use of medicines (also bought by yourself), except for contraceptives Cardiovascular diseases or abnormalities Anomalies of the blood analysis or ECG Psychological disorders pregnancy / lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Clijsen, PhD
Phone
+41 81 3000 175
Email
ron.clijsen@supsi.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Erich Hohenauer, PhD
Phone
+41 81 3000 175
Email
erich.hohenauer@supsi.ch
Facility Information:
Facility Name
Fachhochschule Südschweiz
City
Landquart
State/Province
GR
ZIP/Postal Code
7302
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Clijsen, PhD
Phone
+41 81 3000 175
Email
ron.clijsen@supsi.ch
First Name & Middle Initial & Last Name & Degree
Erich Hohenauer, PhD
Phone
+41 81 3000 175
Email
erich.hohenauer@supsi.ch
Facility Name
Fachhochschule Südschweiz
City
Landquart
State/Province
GR
ZIP/Postal Code
7302
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Clijsen, PhD
Phone
+41 81 3000 175
Email
ron.clijsen@supsi.ch
First Name & Middle Initial & Last Name & Degree
Erich Hohenauer, PhD
Phone
+41 81 3000 175
Email
erich.hohenauer@supsi.ch
First Name & Middle Initial & Last Name & Degree
Ron Clijsen, PhD
First Name & Middle Initial & Last Name & Degree
Erich Hohenauer, PhD
First Name & Middle Initial & Last Name & Degree
Rahel Stoop, MSc
First Name & Middle Initial & Last Name & Degree
Carlina Deflorin, MSc
Facility Name
Fachhochschule Südschweiz
City
Landquart
ZIP/Postal Code
7302
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronaldus Clijsen, PhD
Phone
813000175
Email
ron.clijsen@supsi.ch
First Name & Middle Initial & Last Name & Degree
Thim van der Laan, MA
Phone
813000175
Email
t.vanderlaan@physioschule.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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The Psychophysiological Effect of Simulated and Terrestrial Altitude

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