Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

Conditions

• Motion Sickness, Space
• Motion Simulation
• Parabolic Flight

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• DPI-386 Nasal Gel — DRUG
  Subjects will self-administer DPI-386 Nasal Gel
• Other (e.g., promethazine, meclizine) — DRUG
  Subjects will self-administer other medications as available.

Study Details

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.

Key Dates

Start date

Aug 10, 2021

Status verified

May 2024

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DPI-386 Nasal Gel
  DPI-386 Nasal Gel, 0.4 mg
• Experimental: Control
  Another form of preventative or treatment medication for motion sickness (e.g., promethazine or meclizine)

Primary Outcome Measure

Motion sickness (MS) symptoms using Pensacola Diagnostic Index (PDI) nausea scale. [ Time Frame: 1 week ]

Central Contacts

• Barry Feinberg, MD
  314-697-1330
  [email protected]

Locations (1)

Find similar trials in Houston, TX