Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Psychophysiological Effect of Simulated and Terrestrial Altitude (Hypoxia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075565
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
University of Portsmouth
Vrije Universiteit Brussel
Information provided by (Responsible Party):
University of Applied Sciences and Arts of Southern Switzerland

Brief Summary:
The aim of this study is to compare the psychophysiological effects of terrestrial altitude with a normobaric, hypoxic situation.

Condition or disease Intervention/treatment Phase
Hypoxia Altitude Hypoxia Altitude Sickness Altitude Mountain Sickness Hypoxia, Altitude Behavioral: Terrestrial altitude Behavioral: Cloud 9 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study design is a crossover design.
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Psychophysiological Effect of Simulated and Terrestrial Altitude
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Simulated altitude
The participants are exposed to simulated altitude in a normobaric situation.
Behavioral: Cloud 9

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.


Experimental: Terrestrial altitude
The participants are exposed to terrestrial altitude in a hypobaric situation.
Behavioral: Terrestrial altitude
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.

No Intervention: Control
the participants are exposed to a normoxic and normobaric environment.



Primary Outcome Measures :
  1. Perfusion of the skin microcirculation [ Time Frame: 30 minutes ]
    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.

  2. Oxygenation of the muscles and the brain [ Time Frame: 30 minutes ]
    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.

  3. Oxygenation of the blood [ Time Frame: 30 minutes ]
    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.

  4. Blood pressure [ Time Frame: 30 minutes ]
    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.

  5. Heart rate [ Time Frame: 30 minutes ]
    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.

  6. Skin temperature [ Time Frame: 30 minutes ]
    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.

  7. Concentration of blood lactate and creatine kinase [ Time Frame: 30 minutes ]
    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.

  8. Balance [ Time Frame: 30 minutes ]
    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.

  9. Pain threshold: pain pressure gauge [ Time Frame: 30 minutes ]
    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.

  10. Sleep disorder [ Time Frame: 30 minutes ]
    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.

  11. Altitude sickness [ Time Frame: 30 minutes ]
    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.

  12. Dyspnoea [ Time Frame: 30 minutes ]
    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.

  13. Mental state [ Time Frame: 30 minutes ]
    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.

  14. Cognition [ Time Frame: 30 minutes ]
    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 :
  1. Thermal comfort and sensation [ Time Frame: 30 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075565


Contacts
Layout table for location contacts
Contact: Ron Clijsen, PhD +41 81 3000 175 ron.clijsen@supsi.ch
Contact: Erich Hohenauer, PhD +41 81 3000 175 erich.hohenauer@supsi.ch

Locations
Layout table for location information
Switzerland
Fachhochschule Südschweiz Recruiting
Landquart, GR, Switzerland, 7302
Contact: Ron Clijsen, PhD    +41 81 3000 175    ron.clijsen@supsi.ch   
Contact: Erich Hohenauer, PhD    +41 81 3000 175    erich.hohenauer@supsi.ch   
Fachhochschule Südschweiz Recruiting
Landquart, GR, Switzerland, 7302
Contact: Ron Clijsen, PhD    +41 81 3000 175    ron.clijsen@supsi.ch   
Contact: Erich Hohenauer, PhD    +41 81 3000 175    erich.hohenauer@supsi.ch   
Principal Investigator: Ron Clijsen, PhD         
Sub-Investigator: Erich Hohenauer, PhD         
Sub-Investigator: Rahel Stoop, MSc         
Sub-Investigator: Carlina Deflorin, MSc         
Fachhochschule Südschweiz Recruiting
Landquart, Switzerland, 7302
Contact: Ronaldus Clijsen, PhD    813000175    ron.clijsen@supsi.ch   
Contact: Thim van der Laan, MA    813000175    t.vanderlaan@physioschule.ch   
Sponsors and Collaborators
University of Applied Sciences and Arts of Southern Switzerland
University of Portsmouth
Vrije Universiteit Brussel
Layout table for additonal information
Responsible Party: University of Applied Sciences and Arts of Southern Switzerland
ClinicalTrials.gov Identifier: NCT04075565    
Other Study ID Numbers: 2019-00504
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Applied Sciences and Arts of Southern Switzerland:
hypoxia
altitude
physiology
cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Altitude Sickness
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases