Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance. Motion Sickness Countermeasures Field Test
Sponsor study identifier
interventional
80
1 country
1
Study Start
August 10, 2021
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary specific aim of this Field Test aim is to evaluate the feasibility and efficacy of administering the intranasal scopolamine gel in operational field settings using both astronaut and ground-control subjects that are exposed to provocative motion as part of their assigned duties. For the ground-control subjects, these may include motion simulations (e.g., centrifuge), parabolic flights and/or Orion capsule recovery operations. Astronaut participants may choose to test Inscop during provocative preflight training exercises (e.g., centrifugation), and can choose to take the medication prophylactically to prevent symptoms or after symptom onset to treat motion sickness during the launch and/or landing mission phases. Both ground-control and astronaut participants will be required to test the medication during a training session to monitor for adverse side effects. Participants in the field test aim will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. The investigators will also include field "control" subjects who did not take (INSCOP) to comment on what countermeasures subjects used and their effectiveness. The investigators will be recruiting astronaut participants from free-flier missions (e.g., SpaceX Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2021
Actual (reported)April 17, 2023
Actual (reported)May 10, 2023
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale.
The maximum nausea score (from 0 = none to 3 = severe) will be recorded once for each of the first three inflight days and once for each of the first three postflight days, or once per operational setting not involving spaceflight (e.g., once per simulation or parabolic flight).
1 week
Motion sickness symptom severity using a Subjective Discomfort Rating (SDR).
1 week
Vertigo severity
1 week
DPI-386 Nasal Gel, 0.4 mg
Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)
Subjects will self-administer DPI-386 Nasal Gel
Subjects will self-administer other medications as available.
NASA Johnson Space Center Neuroscience Laboratory
Houston, Texas, 77058, United States
Scott J Wood, PhD
National Aeronautics and Space Administration (NASA)
First Submitted
April 17, 2023
First Posted
May 10, 2023
Study Start
August 10, 2021
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Headache severity
1 week
Drowsiness severity
1 week
Motion sickness impact on performance of functional tasks (from 0 = none to 4 = severe)
1 week
Contact the study team to confirm eligibility.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2024
Record last verified: 2024-05
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