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

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Status and phase: Completed; Phase 4

Conditions: Vestibular

Treatments: Behavioral: Hyper gravity training; Drug: Placebo; Behavioral: No hypergravity training; Drug: Promethazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02136420

497997

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 10 patient groups, including a placebo group

Tilt perception, Training, placebo

Experimental group

Description:

placebo

Treatment:

Drug: Placebo

Behavioral: Hyper gravity training

Tilt perception, No training, placebo

Placebo Comparator group

Description:

subject does test with no hypergravity training and placebo drug only

Treatment:

Behavioral: No hypergravity training

Drug: Placebo

Tilt perception, Training, promethazine

Experimental group

Description:

promethazine 25 mg, one time 120 minutes prior to experiment

Treatment:

Drug: Promethazine

Behavioral: Hyper gravity training

Tilt perception,No training,promethazine

Experimental group

Description:

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

Treatment:

Behavioral: No hypergravity training

Drug: Promethazine

Manual Control, Training, placebo

Experimental group

Description:

placebo

Treatment:

Drug: Placebo

Behavioral: Hyper gravity training

Manual Control, No training, placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: No hypergravity training

Drug: Placebo

Manual Control, Training, promethazine

Experimental group

Description:

promethazine 25 mg, one time 120 minutes prior to experiment

Treatment:

Drug: Promethazine

Behavioral: Hyper gravity training

Manual Control,No training,promethazine

Experimental group

Description:

promethazine 25 mg, one time 120 minutes prior to experiment

Treatment:

Behavioral: No hypergravity training

Drug: Promethazine

Perceptual thresholds,drug then placebo

Experimental group

Description:

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.

Treatment:

Drug: Promethazine

Drug: Placebo

Perceptual thresholds,placebo then drug

Experimental group

Description:

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.

Treatment:

Drug: Promethazine

Drug: Placebo