VIIP syndrome (Visual Impairment and Intracranial Pressure)
Conditions
Interventions
Group 1: 58 days stationary stay at DLR
BDC Phase (Baseline Data Collection)
14 days at normal ambient air
HDT phase (Head Down Tilt)
30 days bed rest with 6° head-down tilt position
CO2 enriched at
Sponsors
Institut für Luft- und Raumfahrtmedizin des DLRs (Helmholzgesellschaft)
Eligibility
Sex/Gender
All
Age
24 Years to 55 Years
Inclusion criteria
Inclusion criteria: - healthy - 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
Exclusion criteria
Exclusion criteria: - 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 Investigation/during the study period - Any other condition which, in the opinion of the examiner, makes the subject suitable for inclusion in the study as unsuitable - Entry in EU and US anti-terrorism databases
Design outcomes
Primary
| Measure | Time frame |
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Secondary
| Measure | Time frame |
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Countries
Germany
Contacts
Public ContactAndrea Nitsche
Deutsches Zentrum für Luft- und Raumfahrt Institut für Luft- und RaumfahrtmedizinStudiensekretariat
Outcome results
None listed