The Psychophysiological Effect of Simulated and Terrestrial Altitude

NCT ID: NCT04075565

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2022-04-30

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.

Conditions

Hypoxia; Altitude Hypoxia; Altitude Sickness; Altitude; Mountain Sickness; Hypoxia, Altitude

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Simulated altitude

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

Group Type: ACTIVE_COMPARATOR

Cloud 9

Intervention Type: BEHAVIORAL

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.

Terrestrial altitude

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

Group Type: EXPERIMENTAL

Terrestrial altitude

Intervention Type: BEHAVIORAL

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.

Control

the participants are exposed to a normoxic and normobaric environment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Portsmouth

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

University of Applied Sciences and Arts of Southern Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fachhochschule Südschweiz

Landquart, Kanton Graubünden, Switzerland

Fachhochschule Südschweiz

Landquart, , Switzerland

Countries

Switzerland

Other Identifiers

2019-00504

Identifier Type: -

Identifier Source: org_study_id