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临床试验/NCT02136420
NCT02136420已完成4 期

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

Faisal_Karmali@MEEI.HARVARD.EDU1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Percent Change in Roll Tilt Perception After Exposure to Hypogravity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must be in general good health

排除标准

  • 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

研究组 & 干预措施

Tilt perception, Training, placebo

Experimental

placebo

干预措施: Hyper gravity training (Behavioral)

Tilt perception, Training, placebo

Experimental

placebo

干预措施: Placebo (Drug)

Tilt perception, No training, placebo

Placebo Comparator

subject does test with no hypergravity training and placebo drug only

干预措施: Placebo (Drug)

Tilt perception, No training, placebo

Placebo Comparator

subject does test with no hypergravity training and placebo drug only

干预措施: No hypergravity training (Behavioral)

Tilt perception, Training, promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: Promethazine (Drug)

Tilt perception, Training, promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: Hyper gravity training (Behavioral)

Tilt perception,No training,promethazine

Experimental

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

干预措施: Promethazine (Drug)

Tilt perception,No training,promethazine

Experimental

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

干预措施: No hypergravity training (Behavioral)

Manual Control, Training, placebo

Experimental

placebo

干预措施: Hyper gravity training (Behavioral)

Manual Control, Training, placebo

Experimental

placebo

干预措施: Placebo (Drug)

Manual Control, No training, placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

Manual Control, No training, placebo

Placebo Comparator

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

干预措施: No hypergravity training (Behavioral)

Manual Control, Training, promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: Promethazine (Drug)

Manual Control, Training, promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: Hyper gravity training (Behavioral)

Manual Control,No training,promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: Promethazine (Drug)

Manual Control,No training,promethazine

Experimental

promethazine 25 mg, one time 120 minutes prior to experiment

干预措施: No hypergravity training (Behavioral)

Perceptual thresholds,drug then placebo

Experimental

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.

干预措施: Promethazine (Drug)

Perceptual thresholds,drug then placebo

Experimental

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.

干预措施: Placebo (Drug)

Perceptual thresholds,placebo then drug

Experimental

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.

干预措施: Promethazine (Drug)

Perceptual thresholds,placebo then drug

Experimental

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.

干预措施: Placebo (Drug)

结局指标

主要结局

Percent Change in Roll Tilt Perception After Exposure to Hypogravity

时间窗: 1 session

Note that this applies to arms 1-4 only. Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz.

Yaw Perceptual Motion Threshold

时间窗: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication

This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity. This outcome measure applies only to arm 5 subjects.

Roll Perceptual Motion Threshold

时间窗: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication

This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal. This outcome measure applies only to arm 5 subjects.

Interaural Perceptual Motion Threshold

时间窗: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication

This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right. This outcome measure applies only to arm 5 subjects.

Percent Change in Manual Control Performance After Exposure to Hypogravity

时间窗: 1 session

Note that this applies to arms 6-9 only. Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz.

次要结局

未报告次要终点

研究者

发起方
Faisal_Karmali@MEEI.HARVARD.EDU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Faisal_Karmali@MEEI.HARVARD.EDU

Primary Investigator

Massachusetts Eye and Ear Infirmary

研究点 (1)

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