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

April 27, 2026 updated by: Jeffrey Eggleston, University of Texas, El Paso
• 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flight performance
Time Frame: 10 minutes per each of the 4 conditions
ability to perform in-flight assigned tasks
10 minutes per each of the 4 conditions
Self-perceived workload
Time Frame: 1 minute to complete the survey, 3 times per condition for 4 conditions
NASA TLX survey
1 minute to complete the survey, 3 times per condition for 4 conditions
Electrodermal activity
Time Frame: 10 minutes per each of the 4 conditions
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas, El Paso

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Eggleston, PhD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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