NASA Human Research Program

1. NASA Human Research Program Behavioral Health and Performance May 11, 2009 Lauren B. Leveton, Ph.D. Element Manager Human Research Program Space Medicine Division/SD3

2. Human/System Integration Process Requirements Development Research How can we do better? Requirements Integration Negotiating project buy-in Operations Lessons learned! Design Hands-on architectural involvement Verification Were requirements met?

3. As Ops views Research… … and, as Research views Ops Flight

4. Flight

5. Ground Evidence: Performance Decrements Ground studies have shown that minor sleep deprivation (no sleep in the past 18 hours) lead to impaired cognitive and motor performance, comparable to impairments seen in those with .05% - .1% blood alcohol levels (Williamson and Feyer, 2000; Dawson and Reid, 1997; Arnedt et al., 2001) Being very impaired after chronic sleep restriction was perceived as only mild fatigue Individuals may not be aware of their performance deficits from inadequate recovery sleep. Laboratory and field studies have found this to be the case (Dinges et al. 1999; Van Dongen et al., 2003; Belenky et al. 2003; Dinges et al., 2005; as cited in Leveton and Dinges, 2006) • A wide range of serious long-term health consequences are associated with chronic, or cumulative, sleep loss: • hypertension • diabetes • obesity • heart attack • stroke • psychiatric disorders such as depression or severe anxiety.

6. Cultural Issues: “To understand sleep – wake activity, let’s study Gyroscopes on the Station”

8. Note: A product may reach CRL/TRL 9 for a particular purpose, but may also restart the TMP Process for additional purposes Research DeliverablesTransition to Medical Operations Research Design & Development Operations Evaluation & Validation 1 2 3 4/5 TMP CRL/TRL 6 7 8 9 CRL 1-3: Hypothesis formulation, validation; CRL 4-5: Concept formulation, proof of feasibility; CRL 6: Lab testing, efficacy; CRL 7: Integrated testing of cm in analog/simulated environment; CRL 8: Validation in spaceflight to demonstrate efficacy and operational feasibility; CRL 9: CM fully flight tested, ready for operational implementation 3/31/09 DRAFT – Pre-Decisional

9. 2014 Mission Operations Requirements Def Medical Operations Constellation/ISS Actigraphy Protocol: -Sleep Diary -Actiwatch -Terrestrial and on-orbit sleep-wake activity HRP Evidence Reports Transition to Ops -Does sleep loss continue on long duration missions, or is there adaptation? -How is performance affected? -How can individual vulnerabilities to sleep loss best be determined? -What are the best tools to monitor and assess decrements due to fatigue, sleep loss, and other spaceflight factors? Informs Gaps Informs Countermeasure Development

10. 2014 Mission Operations Requirements Def Medical Operations Constellation/ISS What are the best tools to monitor and assess decrements due to fatigue, sleep loss, and other spaceflight factors? Obtained normative data from NEEMO crewmembers Developed 3-minute PVT Self Test interface feedback combined with performance algorithm • NEEMO Missions: • Feasibility with astronauts • Norms on astronauts • Sensitivity to fatigue, etc. Psychomotor Vigilance Test -extensively validated with pilots, physicians, shift workers Evaluate PVT SelfTest interface with astronauts who helped develop tests norms and with comparable individuals in analog environments Evidence ISS Study HRP Evidence Reports Transition to Ops Flight Rules MRID

11. 2012 2014 Constellation/ISS Requirements for Lunar Lander Mission Operations Requirements Def Medical Operations How can light be used in flight as a countermeasure? Evidence shows that light serves as an effective countermeasure for circadian entrainment, alertness • Characteristics of Light Constellation Evidence Operational regimen for Using light as countermeasure Ops Acute, mid and long term effects

12. Constellation Medical Operations • Test the sleep-aid medications most commonly used by astronauts • Determine best individual dosages • Assess carry-over effects upon abrupt premature termination of sleep (to simulate an emergency situation) • Transition the data and protocol as best practices for medical operations

13. Actigraphy Protocol PVT Self Test Blue Light Solid State Light Module (SSLM) Individualized Sleep Medication Protocol BHP Research DeliverablesTransition to Medical Practices Research Design & Dev Operations Evaluation and Validation 1 2 3 4/5 TMP c d b a CRL/TRL 6 7 8 9 3/31/09

14. A detailed description of the deliverable or product, its intended use or application, and a description of how the deliverable or product addresses a NASA identified critical risk, medical issue, or application. Data demonstrating the efficacy, effectiveness, or utility of the deliverable or product. Data demonstrating the operational validation of the deliverable or product. An implementation plan of how the product or deliverable is to be used or applied (e.g. protocol, dosing regime, scope of use, etc.). Assessment of spin off effects (e.g. other applications of the product or portions of the product to meet additional operational needs that were not part of the original vision for the product) Example = sleep logs portion of actigraphy protocol is useful for assessing medication efficacy An analysis of the mission resources (e.g. crew time, volume, power, etc.) necessary to implement the product or deliverable. TMP Steps Research Operations Evaluation and Validation 1 2 3 4/5 TMP CRL/TRL 6 9 3/31/09 DRAFT – Pre-Decisional DRAFT – Pre-Decisional

16. CRL Levels 1. PHENOMENON OBSERVED AND REPORTED, PROBLEM DEFINED 2. HYPOTHESIS FORMED, PRELIMINARY STUDIES TO DEFINE PARAMETERS, DEMONSTRATE FEASIBILITY. 3. VALIDATED HYPOTHESIS, UNDERSTANDING OF SCIENTIFIC PROCESSES UNDERLYING PROBLEM. 4. FORMULATION OF COUNTERMEASURES CONCEPT, BASED ON UNDERSTANDING OF PHENOMENON. 5. PROOF OF CONCEPT TESTING AND INITIAL DEMONSTRATION OF FEASIBILITY AND EFFICACY. 6. LABORATORY/CLINICAL TESTING OF POTENTIAL COUNTERMEASURE IN HUMAN SUBJECTS TO DEMONSTRATE EFFICACY OF CONCEPT FOR SPECIFIC PROBLEM. 7. INTEGRATED EVALUATION WITH HUMAN SUBJECTS IN CONTROLLED LABORATORY CONDITIONS SIMULATING OPERATIONAL SPACE FLIGHT ENVIRONMENT. 8. VALIDATION WITH HUMAN SUBJECTS IN ACTUAL OPERATIONAL SPACE FLIGHT TO DEMONSTRATE EFFICACY AND OPERATIONAL FEASIBILITY. 9. COUNTERMEASURE FULLY FLIGHT TESTED AND READY FOR OPERATIONAL IMPLEMENTATION