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Human Experimentation Toolkit for Variable Physiological/Environmental Conditions in an Aerospace Environment

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: Research-based approach to bridge cognitive, physiological, and behavioral metrics for use in a human experimentation toolkit for collecting associated data while participants are exposed to a wide array of physiological and environmental conditions – with focus on hypoxia in the aerospace environment. 

DESCRIPTION: In recent years, physiological events (e.g., hypoxia) have become more prevalent in several aviation platforms including the F/A-18, F-35, T-45, and EA-18G. Although solutions in the oxygen system have been identified and resolved, hypoxia events continue to occur and hypoxia remains the top safety concern across the Naval Aviation Enterprise. Hypoxia research is ongoing in many laboratories within the Department of Defense and other medical research facilities, but these research efforts are lacking a standardized experimentation system that can facilitate replication across laboratories. Replication is fundamental to experimental design [1], and it is imperative to provide the most reliable and valid cognitive, physiological, and behavioral metrics to scientists for investigations into this highly visible research area within the aerospace scientist community. The majority of hypoxia research includes animal modeling [2] or high altitude on land [3] (i.e., mountaineering) observational metrics. This restrictive corpus of published studies is likely due to the high-risk nature of inducing hypoxia in human participants. With the increasing demand for more thorough understanding of human models in hypoxic-hypoxia conditions, it is crucial to provide researchers the necessary tools to comprehensively understand this phenomenon and to have the appropriate metrics for use when sharing their findings [1]. Although the focus of the development this cognitive-behavioral test battery is on hypoxia, the test-battery should be easily adapted to other environmental conditions that may affect the cognitive, physiological, and/or behavioral state of participants (e.g., heat, cold, stress). The reason for expanding this test-battery from solely hypoxia to other environmental conditions is that it is necessary for experimental scientists to parse the similarities and differences of symptomology observed during hypoxia and other physiological symptoms that may be experienced in the aerospace environment. Considerations for the development of the test-battery should include cognitive psychology [4][5], experimental design [1], behavioral psychology [5], human neurophysiology [5], and human-system integration in the aerospace environment. Additionally, the development of this testing toolkit should consider integration with the reduced-oxygen breathing device (ROBD) currently used in training and experimental environments for aviation training and hypoxia training. 

PHASE I: Refine potential tests and associated metrics based on proof-of-concept evaluation to develop into a testing environment based on supporting literature from respective research communities for each metric type. Develop prototype test-bed or conceptual design demonstrating understanding of experimental design and subsequent statistical analyses. Compose Internal Review Board (IRB) protocol for human-subjects testing. Provide documentation demonstrating utility and, if possible, proof-of-concept demo of one or more of the testing components along with a Technology Readiness Level (TRL)/Manufacturing Readiness Level (MRL) assessment. 

PHASE II: If selected for Phase II, this protocol will be submitted to U.S. Army Medical Research and Materiel Command's Office of Research Protections, Human Research Protections Office (HRPO) for approval. Develop, test, and refine test-battery to maximize reliability and validity of tests. Human-subjects testing will be required to reveal suitability of test-battery for the aerospace environment. Efforts will be made to provide reduced-oxygen breathing device (ROBD) and participants via military testing facilities. Phase II should conclude with a software solution composed of multiple testing options for each metric (i.e., behavioral, physiological, and cognitive) and a process to meaningfully assimilate data from the disparate testing and data types. TRL/MRL assessment should be updated. 

PHASE III: Refine to final production configuration. Software specifications and guidebook shall be provided in conjunction with software delivery. Develop manufacturing and logistics process in conjunction with Department of Defense and other government manufacturing engineers and logisticians. Possible testing of system parameters at one or more of the locations listed in the next paragraph. This human experimentation toolkit, although focused on the #1 Naval Aviation safety concern of hypoxia, will be extensible to most human performance research laboratories across the DoD. Potential Government customers including National Aeronautics and Space Administration (NASA), Naval Air Systems Command (NAVAIR), Special Operations Forces Acquisition Technology and Logistics (SOF AT&L), Air Force Research Laboratory (AFRL), Army Research Laboratory (ARL), Office of Naval Research (ONR), Naval Health Research Center (NHRC), and most other human performance laboratories. Initial focus will be placed on NAVAIR as customer for development into DoD experimentation and testing system. This project will result in a human performance research toolkit that will be of great marketing potential in academia and commercial product-based development firms that entail human factors components (e.g., car manufacturers, software development firms, commercial aviation). 

REFERENCES: 

1: Keppel, G. (1991). Design and analysis: A researcher's handbook. Prentice-Hall, Inc.

2:  Gozal, D., Daniel, J. M., & Dohanich, G. P. (2001). Behavioral and anatomical correlates of chronic episodic hypoxia during sleep in the rat. Journal of Neuroscience, 21(7), 2442-2450.

3:  Singh, I., Khanna, P. K., Srivastava, M. C., Lal, M., Roy, S. B., & Subramanyam, C. S. V. (1969). Acute mountain sickness. New England Journal of Medicine, 280(4), 175-184.

4:  Sternberg, R. J., & Sternberg, K. (2016). Cognitive psychology. Nelson Education.

5:  Mesulam, M. M. (2000). Principles of behavioral and cognitive neurology. Oxford University Press.

 

KEYWORDS: Stress Physiology, Cognitive Psychology, Psychophysiology, Experimental Design, Medical Research, Hypoxia, Experimental Methodology 

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