NL-OMON48277已完成不适用
Artificial Gravity Bed rest study - AGBRESA
Department of muscle and bone metabolism0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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
排除标准
- •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 de
研究者
相似试验
已完成
不适用
ong-term Bed Rest Study 2018Artificial Gravity Bed Rest with European Space AgencyMuscular atrophy, bone resorption,Deconditioning of the cardiovascular system, impairment of the vestibular system, impairment of cognitive performance, fluid shifts, eye changes, SANSDRKS00015677DLR - Institut für Luft- und Raumfahrtmedizin24
已完成
不适用
Vibration Bed Rest Studymuscle atropy, bone resorption, deconditioning of the cardio vascular system, deconditioning of the balance ability, cartilage degenerationDRKS00000140Deutsches Zentrum für Luft- und Raumfahrt8
尚未招募
Unknown
Investigating the effect birthing bed stirrups on the mother's birth experienceExperience of using bed stirrups (comfort, ease, and satisfaction).IRCT20160808029255N13Tehran University of Medical Sciences62
终止
不适用
A Multisite Exploration of Balance Perturbations With and Without Body Weight SupportStrokeStroke, AcuteGait, UnsteadyDistorted BalanceImpairment BalanceNCT05110300Gaylord Hospital, Inc114
终止
不适用
Hill-Rom WAVE for Positional Obstructive Sleep Apnea at HomeSleep Apnea, ObstructiveNCT03971721Ohio State University3