ong-term Bed Rest Study 2018Artificial Gravity Bed Rest with European Space Agency
- Conditions
- Muscular atrophy, bone resorption,Deconditioning of the cardiovascular system, impairment of the vestibular system, impairment of cognitive performance, fluid shifts, eye changes, SANS
- Registration Number
- DRKS00015677
- Lead Sponsor
- DLR - Institut für Luft- und Raumfahrtmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Physically and mentally healthy test subjects that are able and declare their willingness to participate in the entire study and successfully passed the psychological and medical screening
- Aged between 24 and 55 years old with a Body Mass Index (BMI) of 19 - 30 kg/m2, height between 153 -190 cm
- Non-smoker, for at least six months before the start of the study
- Capable of completing the study
- Willing to stay in bed with or without weight-bearing (artificial gravity) for 60 days
- Demonstrable medical insurance and official certificate of absence of criminal record
- Demonstrable dentist certificate
- Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)*
- A requirement for any prescription medications
- Vegetarian, vegan (during the study)
- Migraine, chronic headache
- Insomnia or other sleep disorders
- Previous psychiatric illness
- Claustrophobia
- Increased intraocular pressure
- Any eye disorder that could significantly impact or jeopardize visual function
- Hyperopia > +5.0 Diopters
- Myopia > - 6 Diopters
- Astigmatism > 3 Diopters
- History of laser surgery, glaucoma and retinal surgery
- Hiatus hernia
- Gastro-oesophageal reflux
- Gastrointestinal stenosis, dysphagia
- Current or history of chronic bowel disease
- Diabetes mellitus
- Rheumatic illness
- Current or a history of (chronic) pulmonary disease
- Current muscle or joint disease or disorder
- History of prolapsed intervertebral disc
- Chronic back complaints
- Bone fractures less than 1 year prior to study
- Kidney disorder: deviations from normal values for creatinine in plasma. Deviations from normal values (Normal values for creatinine in plasma < 1.20 mg/dl)** and eGFR***
- History of kidney stones
- History of (chronic) cystitis, hydronephrosis, pyelonephritis
- Anaemia: Hb under normal values. (Normal values of Hb for men: 13.0-17.5 g/dl; women 12.0-16.0 g/dl)**
- Elevated risk of thrombosis ****
- Pronounced orthostatic intolerance (< 10 min standing and/or not able to withstand artificial gravity)
- History of elevated intracranial pressure and associated central nervous disorders
- Current or history of hemorrhagic diathesis or coagulations disorders
- History of spinal cord disease, including radiculopathy, myelopathy, or neuropathy
- History of skull/cranial surgeries
- History of adverse events to local anesthesia
- An abnormal androgen or estrogen status (tested only upon speculation)
- Female candidate is pregnant
- Female candidate is on oral contraceptives or contraceptive patch up to 4-6 months prior to study start
- Female candidate is in menopause or post-menopause, or is on hormone replacement therapy
- Female subjects without a normal length menstrual cycle (20-36 days)
- Inability or unwillingness to perform the required tests
- A medical or orthopedic condition that would preclude bed rest or exercise, as is determined by the examining and overseeing physician of the bed rest study
- Not within two standard deviations of normal bone mineral density (measured by dual-energy x-ray absorptiometry) for hip and lumbar spine based on T-score (young adult-peak bone mass, Caucasian, sex, but not age-adjusted)
- Metal implants (or objects like metallic slivers in the eyes, or bullets or shrapnel in the body) or other kinds of bone synthesis materials that are not well-fixed; tattoos or permanent make-up incompatible with MRI
- Participation in a (clinical) study within the last 3 months before start of this study that confounds participation in the AGBRESA study
- Known history of vertigo, nystagmus, neurological conditions, vestibular or gait disorders
- Previous heart surgery
- History of cerebrovascular or brain disease, tumor, injury, surgery or malformation
- Disorders of CSF circulation (i.e. hydrocephalus, idiopathic intracranial hypertension)
- Tinnitus; sensorineural hearing loss > 30 dB, or implanted hearing device
- Known Chiari-malformation
- History of fracture(s) at proximal femur (hip area), less than 2 years, and/or with remainin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method s. Appendix endpoints
- Secondary Outcome Measures
Name Time Method s. Appendix endpoints