NCT05867719

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

May 4, 2026

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

April 13, 2023

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Normoxic

NO INTERVENTION

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.

Simulated 8,000 feet hypoxic

EXPERIMENTAL

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

Simulated 12,000 feet hypoxic

EXPERIMENTAL

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

Ramp hypoxic exposure

EXPERIMENTAL

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

Interventions

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.

Ramp hypoxic exposureSimulated 12,000 feet hypoxicSimulated 8,000 feet hypoxic

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets body composition standards for the US Navy Active-duty personnel based on height and weight
  • Normal vision/corrected to normal vision

You may not qualify if:

  • Respiratory Deficiencies
  • Cardiovascular Disorders
  • Neurological/Musculoskeletal Disorders
  • Photosensitive Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at El Paso

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jeffrey Eggleston, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Kinesiology

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 22, 2023

Study Start

August 1, 2023

Primary Completion

April 27, 2026

Study Completion

April 27, 2026

Last Updated

May 4, 2026

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations