DRKS00023491已完成未知
Medium-term Bed Rest Study 2017VIIP and Psychological :envihab Research StudyExamination of the VIIP syndrome (Visual Impairment and Intracranial Pressure;Engl. visual impairment and intracranial pressure) and physiological and psychological effects30-day bed rest in 6° head-down position under the influence of increased CO2 atmosphere - VaPER
Institut für Luft- und Raumfahrtmedizin des DLRs (Helmholzgesellschaft)0 个研究点目标入组 12 人开始时间: 2022年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- N/a: Single Arm 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
- •- Body Mass Index (BMI) from 19 - 30 kg/m2
- •- Body height from 153-190 +/- 1 cm
- •- Non-smoker, for at least six months before the inclusion examination
- •- Subjects who are willing and able to participate in the entire study,
- •- subjects who are willing to spend 30 days in bed in an atmosphere enriched with 0.5% CO2
- •- Certificate of health insurance and police clearance certificate
- •- Successful completion of the medical and psychological inclusion examination
- •- Present consent form at the beginning of the study
排除标准
- •- drug, medication or alcohol abuse (regular consumption of more than 20 - 30 g alcohol/day)
- •- Need for any form of prescription medication
- •- Smoking (also e-cigarettes, shisha, e-shisha etc.)
- •- vegetarianism, veganism
- •- Migraine or chronic headaches
- •- Insomnia or other sleep disorders
- •- Current or past mental illness
- •- Claustrophobia (fear of being locked up, either actually or perceived)
- •- Increased intraocular pressure
- •- Eye problems with a significant impact on vision
- •- Laser eye surgery to correct visual acuity
- •- Hiatus hernia (diaphragmatic hernia)
- •- Gastroesophageal reflux
- •- Gastrointestinal constrictions, difficulty swallowing
- •- Current or past chronic intestinal diseases
- •- Diabetes mellitus
- •- Rheumatic diseases
- •- Current or past (chronic) lung diseases
- •- muscle and joint diseases
- •- Current or past herniated disc
- •- Chronic back pain
- •- Bone fractures from 1 year before study
- •- Kidney disease (deviations from standard values for creatinine in plasma, standard value of creatinine < 1.20 mg/dl )*
- •- kidney stones
- •- (Chronic) cystitis, hydronephrosis (water sack kidney), inflammation of renal pelvis
- •- Anaemia: Haemoglobin below normal value (normal value for Hb in men: 13.0 - 17.5 g/dl; in
- •Women: 12.0 - 16.0 g/dl)*
- •- Increased risk of thrombosis **
- •- Pronounced orthostatic intolerance (< 10 minutes standing)
- •- Increased intracranial pressure and related diseases of the central nervous system
- •- Current or past bleeding tendency or coagulation disorders
- •- Past spinal column or skull operations
- •- Incompatibility with local anesthetics
- •Abnormal androgen or estrogen levels
- •- For female candidates:
- •o Existing pregnancy
- •o Taking oral contraceptives (pill) or using other hormone-based contraceptives
- •(contraceptive ring, contraceptive patch etc.) in the last 4-6 months before
- •Start of studies
- •o Menopause or post-menopause or existing hormone replacement therapy
- •o deviations from a stable menstrual cycle (26-32 days). For proof
- •the body temperature in two consecutive cycles immediately after the
- •Waking up before getting up can be measured and documented
- •- Inability or unwillingness to perform the required tests
- •- Any medical or orthopedic condition that requires participation in bed rest or a
- •interfere with the tests to be performed
- •- Bone density of femur and lumbar spine (L1-4) < -2.0 SD t-Score
- •- metal implants or other osteosynthesis materials that are not MRI-compatible, or
- •impede investigations due to their location
- •- Participation in another clinical trial within the last 3 months before the start of this
- 另有 4 项未显示
研究者
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