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
- Conditions
- VIIP syndrome (Visual Impairment and Intracranial Pressure)
- Registration Number
- DRKS00023491
- Lead Sponsor
- Institut für Luft- und Raumfahrtmedizin des DLRs (Helmholzgesellschaft)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method see attachment
- Secondary Outcome Measures
Name Time Method see attachment<br>