Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Adaptation to altered gravity has been of concern from the earliest reports of space motion sickness, through the Apollo exploration era, and into current planning of exploration missions. The proposed research program takes a new approach which could lead to an effective, practical and acceptable protocol for preadapting astronauts to space flight. By using the gravito-inertial alterations possible with centrifugation in different body orientations the investigators will quantify an individual's sensory adaptation capability and use it to predict and to minimize the consequences of movement in any other gravity environment - eventually including weightlessness. The investigators will also study whether a drug (promethazine) affects motion perception and motion sickness.

Conditions

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Vestibular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The design includes three separate studies:

1. Arm 9\&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.
2. Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.
3. Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Double masking applies to arms 9\&10. Other arms use participant masking only.

Study Groups

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Tilt perception, Training, placebo

placebo

Group Type EXPERIMENTAL

Hyper gravity training

Intervention Type BEHAVIORAL

Subject receives hypergravity training before testing

Placebo

Intervention Type DRUG

Placebo

Tilt perception, No training, placebo

subject does test with no hypergravity training and placebo drug only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

No hypergravity training

Intervention Type BEHAVIORAL

Subjects do not receive normal Earth gravity

Tilt perception, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

Hyper gravity training

Intervention Type BEHAVIORAL

Subject receives hypergravity training before testing

Tilt perception,No training,promethazine

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

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

No hypergravity training

Intervention Type BEHAVIORAL

Subjects do not receive normal Earth gravity

Manual Control, Training, placebo

placebo

Group Type EXPERIMENTAL

Hyper gravity training

Intervention Type BEHAVIORAL

Subject receives hypergravity training before testing

Placebo

Intervention Type DRUG

Placebo

Manual Control, No training, placebo

subject does test with no hyper gravity training and placebo drug only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

No hypergravity training

Intervention Type BEHAVIORAL

Subjects do not receive normal Earth gravity

Manual Control, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

Hyper gravity training

Intervention Type BEHAVIORAL

Subject receives hypergravity training before testing

Manual Control,No training,promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

No hypergravity training

Intervention Type BEHAVIORAL

Subjects do not receive normal Earth gravity

Perceptual thresholds,drug then placebo

Subjects 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.

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

Placebo

Intervention Type DRUG

Placebo

Perceptual thresholds,placebo then drug

Subjects 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.

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

Subject receives promethazine

Placebo

Intervention Type DRUG

Placebo

Interventions

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Promethazine

Subject receives promethazine

Intervention Type DRUG

Hyper gravity training

Subject receives hypergravity training before testing

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

No hypergravity training

Subjects do not receive normal Earth gravity

Intervention Type BEHAVIORAL

Other Intervention Names

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Phenergan corn starch

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes