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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.

Training, placeboplacebo

No hypergravity training, placebosubject does test with no hyper gravity training and placebo drug only

Training, promethazinepromethazine 25 mg, one time 120 minutes prior to experiment

No hypergravity training, promethazinepromethazine 25 mg, one time 120 minutes prior to experiment

Perceptual motion threshold testingSubjects 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 and once with promethazine, separated by >4 days.

Study Status

Suspended

Start Date: June 2014

Completed Date: July 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Rate of recovery of roll tilt perception/manual control errors after exposure to hypergravity

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

Discuss Promethazine