Vestibular | Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Vestibular research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PromethazineSubject receives promethazine
Behavioral:Hyper gravity trainingSubject receives hypergravity training before testing
Behavioral:No hypergravity trainingSubjects do not receive normal Earth gravity
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Tilt perception, Training, placeboplacebo
Tilt perception, No training, placebosubject does test with no hypergravity training and placebo drug only
Tilt perception, Training, promethazinepromethazine 25 mg, one time 120 minutes prior to experiment
Tilt perception,No training,promethazinepromethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training
Manual Control, Training, placeboplacebo
Manual Control, No training, placebosubject does test with no hyper gravity training and placebo drug only
Manual Control, Training, promethazinepromethazine 25 mg, one time 120 minutes prior to experiment
Manual Control,No training,promethazinepromethazine 25 mg, one time 120 minutes prior to experiment
Perceptual thresholds,drug then placeboSubjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days. This arm corresponds to results published in Diaz-Artiles et al 2017.
Perceptual thresholds,placebo then drugSubjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days. This arm corresponds to results published in Diaz-Artiles et al 2017.
Start Date: June 2014
Completed Date: December 2016
Phase: Phase 4
Primary Outcome: Percent Change in Roll Tilt Perception After Exposure to Hypogravity
Study sponsors, principal investigator, and references
Principal Investigator: Faisal Karmali, Ph.D.
Lead Sponsor: Faisal_Karmali@MEEI.HARVARD.EDU
Collaborator: National Space Biomedical Research Institute
Diaz-Artiles A, Priesol AJ, Clark TK, Sherwood DP, Oman CM, Young LR, Karmali F. The Impact of Oral Promethazine on Human Whole-Body Motion Perceptual Thresholds. J Assoc Res Otolaryngol. 2017 Aug;18(4):581-590. doi: 10.1007/s10162-017-0622-z. Epub 2017 Apr 24.