Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02976168
Eligibility Criteria:
Inclusion Criteria:
* Physically and mentally healthy male test subjects that are able and declare in writing their willingness to participate in the entire study and successfully passed the psychological and medical screening
* Aged between 18-55 years old with a Body Mass Index (BMI) of 20-28 kg/m2, weight between 65-100 kg, and a height between 158-195 cm
* Demonstrable medical insurance and official certificate of absence of criminal record
Exclusion Criteria:
* Inability to sleep on the back
* Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
* Smoking within the past 6 months prior to study commencement
* Migraine or other chronic head aches
* Previous psychiatric illness
* Subjects suffering from weak concentration
* History of psychological or central nervous disorders
* Hiatus hernia
* Gastro-oesophageal reflux
* Diabetes mellitus
* Pronounced orthostatic intolerance (\< 10 min standing)
* Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine \< 1.20 mg/dl)
* Thyroid gland disorder: deviations from normal values for thyroid stimulating Hormone (TSH) in plasma. (Normal range: TSH 0.55-4.80 mUnits/l)
* Anaemia: Hb under normal values (Normal values of Hb for men: 13.5-17.5 g/l)
* Elevated risk of thrombosis
* High likelihood of coagulopathy assessed by a clinical standard questionnaire
* Chronic back complaints
* History of lumbar surgery
* History of lumbar spine trauma
* Motor or sensory deficits as assessed by neurological examination
* Contraindications against MRI
* Imprisoned at the time of the study
* Taking medications that may impair cognitive function, autonomic function or any of the study procedures
* Ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye trauma or implants
* Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02976168
Study Brief:
Protocol Section:
NCT02976168