Clinical trial NCT02136420: Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Official title: Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vestibular
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Space Biomedical Research Institute
name: Massachusetts Institute of Technology
First posted: 2014-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Roll Tilt Perception After Exposure to Hypogravity
timeFrame: 1 session
measure: Yaw Perceptual Motion Threshold
timeFrame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
measure: Roll Perceptual Motion Threshold
timeFrame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
measure: Interaural Perceptual Motion Threshold
timeFrame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
measure: Percent Change in Manual Control Performance After Exposure to Hypogravity
timeFrame: 1 session
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Faisal Karmali, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.