Functional MRI assessment of arterial and cardiopulmonary baroreflexes and hypoxic/hyperoxic chemoreflexes in the human brainstemPilot study

Deutsches Zentrum für Luft- und Raumfahrt (DLR), Institut für Luft- und Raumfahrtmedizin, Abteilung Kardiovaskuläre Luft- und Raumfahrtmedizin (KLM)0 sites12 target enrollmentDecember 11, 2017

Conditionshealthy volunteers

Overview

Phase: 未知
Intervention: Not specified
Conditions: healthy volunteers
Sponsor: Deutsches Zentrum für Luft- und Raumfahrt (DLR), Institut für Luft- und Raumfahrtmedizin, Abteilung Kardiovaskuläre Luft- und Raumfahrtmedizin (KLM)
Enrollment: 12
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 11, 2017

End Date

June 22, 2018

Last Updated

last year

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Deutsches Zentrum für Luft- und Raumfahrt (DLR), Institut für Luft- und Raumfahrtmedizin, Abteilung Kardiovaskuläre Luft- und Raumfahrtmedizin (KLM)

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\-40 years old with a Body Mass Index (BMI) of 19\-28 kg/m2, weight between 60\-100 kg, and a height between 160\-195 cm
•Non\-smoker, for at least six months before the start of the study
•Demonstrable medical insurance
•Normal blood pressure (lower than 140 over 90\)
•intact pharmacological baroreflex heart rate response for continuing fMRI study
•inconspicuous routine diagnostic laboratories concerning endocrine diseases, renal or hepatic dysfunction, autoimmune diseases, musculoskeletal diseases

Exclusion Criteria

•Medical history is assessed during medical inclusion.
•1\. Neurological conditions including strokes, brain haemorrhage, aneurysms, brain tumours, neurodegenerative diseases, seizures, head trauma based on medical history.
•2\. Cardiopulmonary conditions including coronary artery disease, myocardial infarction, heart failure, ventricular or atrial arrhythmias, pacemaker, recurrent syncope, autonomic disorders, chronic pulmonary diseases (COPD, severe asthma, pulmonary fibrosis), sleep apnea, insomnia or narcolepsy based on medical history. Diseases with compensatory hypertension (e.g. coarctation of the aorta, arteriovenous shunting).
•3\. Active or previous psychiatric conditions including depression, anxiety, bipolar disorder, ADHD based on medical history.
•4\. Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements. This includes, for instance, drug, medication or alcohol abuse (regular consumption of more than 20\-30 g alcohol/day), migraine, or taking medications that may impair cognitive function, autonomic function or any of the study procedures.
•5\. Congenital (Leber’s) optic atrophy or tobacco amblyopia.
•metal implants or active medical devices