Phase 4
N=30
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Vestibular
Bottom Line
View on ClinicalTrials.gov: NCT02136420 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Percent Change in Roll Tilt Perception After Exposure to Hypogravity — 27.0 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Promethazine (Drug); Hyper gravity training (Behavioral); Placebo (Drug); No hypergravity training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- [email protected]
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Roll Tilt Perception After Exposure to Hypogravity |
27.0 | — |
| PRIMARY Yaw Perceptual Motion Threshold |
.83; .92; .86; 1.06 | — |
| PRIMARY Roll Perceptual Motion Threshold |
.27; .32; .39; .39 | — |
| PRIMARY Interaural Perceptual Motion Threshold |
.57; .78; .77; .80 | — |
| PRIMARY Percent Change in Manual Control Performance After Exposure to Hypogravity |
75.4 | — |
Summary
The investigators will study adaptation of motion perception and manual control in altered gravity, including the effects of a drug (promethazine). The investigators will also study whether promethazine affects motion perceptual thresholds.
Eligibility Criteria
Inclusion Criteria
- Subjects must be in general good health
Exclusion Criteria
- Anyone who is not generally in good general health does not qualify
- Cardiovascular disease
- Severe diabetes
- Respiratory condition (e.g. asthma or emphysema)
- Narrow angle glaucoma
- Prostatic hypertrophy
- Gastrointestinal disorders
Data sourced from ClinicalTrials.gov (NCT02136420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.