brain metabolism MedDRA version: 14.1 Level: PT Classification code 10033316 Term: Oxygen saturation System Organ Class: 10022891 - Investigations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Men and women aged between 18 and 35 years - Non-smokers - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria Any of the following will exclude a subject from the study: - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Presence or history of a severe medical condition as judged by the clinical investigator - Presence or history of arterial hypertension - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive) - Blood donation during the previous three weeks - Abnormalities in the 12-lead electrocardiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MR spectroscopy (MRS);Secondary Objective: High energy phosphates Metabolites: glutamine, glutamate, GABA, tCr, NAA and choline;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: on study day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability;Timepoint(s) of evaluation of this end point: on study day | — |
Countries
Austria
Contacts
Medizinische Universität Wien