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临床试验/NCT06467825
NCT06467825招募中不适用

Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent

National Aeronautics and Space Administration (NASA)1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年8月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
Heart Rate

研究概览

简要总结

The purpose of Lunar OI (Orthostatic Intolerance) is to determine if there are differences between males and females in tolerance to and cardiovascular responses during different angles of head-up tilt simulating gravity levels less than or equal to Earth's gravity. Also, this study will determine if a gradient compression garment affects tolerance to tilting and the cardiovascular stress at different tilt angles. Males and females are being identified by biological sex. This will be a two-phased study design. In Phase I we will determine whether there are differences in the development of signs or symptoms of orthostatic intolerance between males and females when tilted head up on a table to different angles to simulate gravity levels that astronauts may experience when landing on or launching from the surface of the Moon. In Phase II, the tilt tests simulating the same gravity levels from Phase I will be repeated, but a custom-made lower-body compression garment will be worn to see if wearing the garment affects the development of orthostatic intolerance. For both study phases, before tilting, a drug will be administered to reduce the amount fluid in the blood (plasma) to levels similar to that experienced by astronauts during spaceflight.

详细描述

Phase I, Visit one Alpha (1A);

OIG (Orthostatic Intolerance Garment) Measurement:

Participants will lie supine while torso and anthropometric measurements are acquired. The investigators will utilize the same procedures developed and adopted by the Orion Program to obtain foot, leg, and torso circumference measurements at pre-determined intervals. This detailed measurement procedure has shown to be effective at providing precise compression levels at pre-determined anatomical locations. The target levels of compression will be verified by the manufacturer, using a Hosiery and Allied Trades Research Association (HATRA) test instrument that is identified in the British Standard for testing compression in elastic stockings.

Tilt Familiarization:

Participants will be instructed to lie supine without moving throughout the Familiarization tilt test. After instrumentation with brachial blood pressure, continuous blood pressure monitoring, and electrocardiogram (ECG) for heart rate, baseline measures will be obtained for at least 2 minutes while the test is explained. Participants will be tilted to 80˚ head-up and instructed to remain still and quiet. After allowing the participant to become familiar with the tilt procedure and the feeling of being upright, the bed will be lowered back to horizontal (flat) and a timer started for a 20-minute supine rest period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pass a test subject screening facility modified Air Force Class III physical

排除标准

  • Known allergy to furosemide or sulfa drugs
  • Currently taking drugs or medications known to adversely interact with furosemide, including but not limited to aspirin, NSAIDs, antibiotics, or immunosuppressant drugs
  • Systemic diseases or current medications known to influence the cardiovascular system
  • Renal disease
  • Type II Diabetes
  • Pregnant participants will be excluded (a urine pregnancy screen will be made available).

研究组 & 干预措施

Hypovolemic

Experimental

Furosemide and potassium supplement.

干预措施: Potassium Supplement (Drug)

Hypovolemic

Experimental

Furosemide and potassium supplement.

干预措施: Furosemide 20 MG (Drug)

Hypovolemic plus garment

Experimental

Furosemide and potassium supplement plus OIG.

干预措施: Potassium Supplement (Drug)

Hypovolemic plus garment

Experimental

Furosemide and potassium supplement plus OIG.

干预措施: Furosemide 20 MG (Drug)

Hypovolemic plus garment

Experimental

Furosemide and potassium supplement plus OIG.

干预措施: Compression Garment (Device)

结局指标

主要结局

Heart Rate

时间窗: 0-20 minutes

beats per minute

Plasma Volume

时间窗: 7-8 hours

Plasma volume and change in plasma volume is calculated using the Dill and Costill equation cited here: Dill DB, Costill DL. Calculation of percentage changes in volumes of blood, plasma, and red cells in dehydration.

Blood Pressure

时间窗: 0-20 minutes

systolic and diastolic, continuous blood pressure

Tilt Tolerance Time

时间窗: 0-20 minutes

duration of Tilt Test

次要结局

未报告次要终点

研究者

发起方
National Aeronautics and Space Administration (NASA)
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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