DRKS00030848已完成Unknown
Visual disturbances and neurological changes after stays in space - a study of possible countermeasures - SANS-CM 3+4
DLR- Deutsches Zentrum für Luft- und Raumfahrt / Institut für Luft- Und Raumfahrtmedizin0 个研究点目标入组 24 人开始时间: 2022年12月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 24 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Male and female, healthy volunteers aged 24-55 years with a body mass index (BMI) of 19-30 kg/m2 and a height of 153-190 cm.
- •- Non-smokers, smoking cessation at least six months prior to study entry
- •- Subjects who are willing and able to participate in the entire study
- •- Present certificate from a health insurance company and police clearance certificate
- •- Successful completion of the medical and psychological inclusion examination
- •- Informed consent available at the beginning of the study
- •- Presentation of a dental certificate
排除标准
- •- Any illnesses, injuries or medical conditions that could prevent safe participation in the study or result in a significant bias in the scientific results
- •- Drug, medication or alcohol abuse (regular consumption of more than 30 g alcohol/day).
- •- Need for any form of prescription medication. Exception: hormonal contraceptives, which do not cause a significant increase in the risk of thrombosis. In this case, hormonal contraception must be used for the entire duration of the study.
- •- Smoker (also e-cigarettes, shisha, e-shisha etc.)
- •- Vegetarianism, veganism during the study
- •- Claustrophobia (fear of actual or perceived confinement, fear of confined spaces)
- •- Increased intraocular pressure
- •- Eye problems with a significant impact on vision
- •- Laser eye surgery to correct visual acuity
- •- Severe long-sightedness > +5 dpt.
- •- Astigmatism (astigmatism of the cornea) > 3 dpt.
- •- Significant chronic complaints due to gastro-oesophageal reflux (heartburn)
- •- Current or past disc herniation
- •- Chronic back pain
- •- Kidney stones, current or past
- •- Increased risk of thrombosis *
- •- Pronounced orthostatic intolerance (blood pressure regulation disorder occurring when changing to an upright position (orthostasis) )
- •- Current or past bleeding tendency or coagulation disorders.
- •- In female candidates:
- •- Existing pregnancy or breastfeeding
- •- Menopause or post-menopause
- •- Any medical or orthopaedic condition that would interfere with participation in the bed rest or any of the examinations to be performed (e.g. diabetes, severe rheumatism, hypertension requiring treatment, etc.). The decision is up to the study doctor.
- •- Bone density of femur and lumbar spine (L1-4) < -2.0 SD t-score
- •- Metal implants, other osteosynthesis materials, implants, tattoos or permanent make-up which are not MRI compatible or which interfere with examinations due to their location.
- •- Participation in another clinical trial within the last 3 months prior to the start of this study, if the study design conflicts with this study (e.g. certain drug trials)
- •- Chronic tinnitus, severe hearing loss or implanted hearing aid
- •- Allergies to an extent that requires the constant presence of an emergency kit
- •- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study
- •- Entry in EU and US counter-terrorism databases
研究者
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