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NCT05867719 Clinical Trial

The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks

Altitude Hypoxia Clinical Trial

Official title:
The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05867719
Other study ID # 2042946-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2023
Est. completion date December 2023

Study information
Verified date June 2023
Source University of Texas, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

• The purpose of this study is to investigate which physiological process that controls normal human body homeostasis is affected by low levels of acute hypoxic exposure and whether there is a difference in those physiological processes and simulated flight performance between a rapid and ramp hypoxic exposure. To accomplish this, pilot analogs will be exposed to normoxic, simulated 8,000 ft (2438 m), simulated 12,000 ft (3658 m), and a ramp exposure breathing at simulated 8,000 ft for 5 minutes before ascending to simulated 12,000 ft while flying in a flight simulator. During the flight simulator, participants will need to accomplish three tasks: 1) Maintaining an altitude of 5,000 ft of elevation while performing a mental math test, 2) Flying the aircraft through the center of a series of 7 targets, and 3) Taking off and flying the aircraft a short distance to land on the center of an indicated target. Physiological measures of heart rate variability (HRV), blood pressure (BP), peripheral oxygen saturation (SpO2), electrodermal activity (EDA), and neck neuromuscular activity using electromyography (EMG) will be measured for this study. Along with questionnaires to assess hypoxic symptoms, simulator sickness, and self-perceived workload for each task

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Meets body composition standards for the US Navy Active-duty personnel based on height and weight - Normal vision/corrected to normal vision Exclusion Criteria: - Respiratory Deficiencies - Cardiovascular Disorders - Neurological/Musculoskeletal Disorders - Photosensitive Epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Hypoxic breathing conditions
Participants will undergo three separate hypoxic conditions, along with a normoxic condition, simulating 8,000 foot elevation, 12,0000 foot elevation, and a ramp condition starting at 8,000 feet and then ascending to 12,000 feet.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Texas, El Paso

Outcome
Type Measure Description Time frame Safety issue
Primary Flight performance ability to perform in-flight assigned tasks 10 minutes per each of the 4 conditions
Primary Self-perceived workload NASA TLX survey 1 minute to complete the survey, 3 times per condition for 4 conditions
Primary Electrodermal activity electrical characteristics of the skin observed as changes in the resistance of the skin to a small electrical current 10 minutes per each of the 4 conditions
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