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

Primary Purpose

Altitude Hypoxia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoxic breathing conditions
Sponsored by
University of Texas, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Altitude Hypoxia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Normoxic

    Simulated 8,000 feet hypoxic

    Simulated 12,000 feet hypoxic

    Ramp hypoxic exposure

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Flight performance
    ability to perform in-flight assigned tasks
    Self-perceived workload
    NASA TLX survey
    Electrodermal activity
    electrical characteristics of the skin observed as changes in the resistance of the skin to a small electrical current

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    June 1, 2023
    Sponsor
    University of Texas, El Paso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05867719
    Brief Title
    The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks
    Official Title
    The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas, El Paso

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Altitude Hypoxia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normoxic
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Simulated 8,000 feet hypoxic
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Simulated 12,000 feet hypoxic
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Ramp hypoxic exposure
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Hypoxic breathing conditions
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Flight performance
    Description
    ability to perform in-flight assigned tasks
    Time Frame
    10 minutes per each of the 4 conditions
    Title
    Self-perceived workload
    Description
    NASA TLX survey
    Time Frame
    1 minute to complete the survey, 3 times per condition for 4 conditions
    Title
    Electrodermal activity
    Description
    electrical characteristics of the skin observed as changes in the resistance of the skin to a small electrical current
    Time Frame
    10 minutes per each of the 4 conditions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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