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

• 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

Study Overview

• Status: Completed
• Conditions: Altitude Hypoxia
• Intervention / Treatment: Other: Hypoxic breathing conditions

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79902
      • University of Texas at El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normoxic; Participants will complete three flight simulator tasks at a normoxic (baseline) altitude. 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.
Experimental: Simulated 8,000 feet hypoxic; Participants will complete three flight simulator tasks at a simulated 8,000 foot altitude. 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.	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.
Experimental: Simulated 12,000 feet hypoxic; Participants will complete three flight simulator tasks at a simulated 12,000 foot altitude. 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.	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.
Experimental: Ramp hypoxic exposure; Participants will complete three flight simulator tasks in a ramp exposure breathing at simulated 8,000 feet for five minutes before ascending to simulated 12,000 feet 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flight performance	ability to perform in-flight assigned tasks	10 minutes per each of the 4 conditions
Self-perceived workload	NASA TLX survey	1 minute to complete the survey, 3 times per condition for 4 conditions
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

Collaborators and Investigators

• Sponsor: University of Texas, El Paso
• Investigators: Principal Investigator: Jeffrey Eggleston, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): April 27, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: 2042946-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No