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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?

Vestibular

Study Interventions

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

Drug:PlaceboPlacebo

Behavioral:No hypergravity trainingSubjects do not receive normal Earth gravity

Study Arms

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.

Study Status

Completed

Start Date: June 2014

Completed Date: December 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Percent Change in Roll Tilt Perception After Exposure to Hypogravity

Secondary Outcome:

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

More information:https://clinicaltrials.gov/show/NCT02136420

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.

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