Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
Motion Sickness, Space, Motion Sickness, Sea Sickness
About this trial
This is an interventional treatment trial for Motion Sickness, Space focused on measuring wave motion, eye-hand coordination, artificial horizon
Eligibility Criteria
Inclusion Criteria: Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently." No participants should have neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test < 7 days prior to study drug administration or no COVID 19 symptoms up to 10 days prior to study drug administration. Exclusion Criteria: Subjects will be excluded if they are taking other drugs that are capable of causing CNS effects such as antihistamines, tricyclic antidepressants, and muscle relaxants or have hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.
Sites / Locations
- NASA Johnson Space Center Neuroscience LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
DPI-386 Nasal Gel
Placebo Comparator
DPI-386 Nasal Gel and Sensory Augmentation DPI-386 Nasal Gel, 0.4 mg
Placebo Comparator and Sensory Augmentation Placebo Nasal Gel
DPI-386 Nasal Gel, 0.4 mg
Placebo Nasal Gel
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL
8-Channel K-Tactile Belt, Engineering Acoustics, Inc., Casselberry, FL