Clinical trial NCT04075565: The Psychophysiological Effect of Simulated and Terrestrial Altitude
Official title: The Psychophysiological Effect of Simulated and Terrestrial Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Altitude Hypoxia
Altitude Sickness
Altitude
Mountain Sickness
Hypoxia, Altitude
Keywords: hypoxia
altitude
physiology
cognition
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: University of Portsmouth
name: Vrije Universiteit Brussel
First posted: 2019-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design is a crossover design.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Perfusion of the skin microcirculation
timeFrame: 30 minutes
measure: Oxygenation of the muscles and the brain
timeFrame: 30 minutes
measure: Oxygenation of the blood
timeFrame: 30 minutes
measure: Blood pressure
timeFrame: 30 minutes
measure: Heart rate
timeFrame: 30 minutes
measure: Skin temperature
timeFrame: 30 minutes
measure: Concentration of blood lactate and creatine kinase
timeFrame: 30 minutes
measure: Balance
timeFrame: 30 minutes
measure: Pain threshold: pain pressure gauge
timeFrame: 30 minutes
measure: Sleep disorder
timeFrame: 30 minutes
measure: Altitude sickness
timeFrame: 30 minutes
measure: Dyspnoea
timeFrame: 30 minutes
measure: Mental state
timeFrame: 30 minutes
measure: Cognition
timeFrame: 30 minutes
Secondary outcomes:
measure: Thermal comfort and sensation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: Fachhochschule Südschweiz
state: GR
city: Landquart
country: Switzerland
facility: Fachhochschule Südschweiz
Study officials:
References: