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Effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MRI

Effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MRI - MR Hyperoxia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005299-32-AT
Enrollment
Unknown
Registered
2012-12-17
Start date
2013-01-24
Completion date
Unknown
Last updated
2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain metabolism MedDRA version: 14.1 Level: PT Classification code 10033316 Term: Oxygen saturation System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Sauerstoff medizinisch Messer Product Name: Sauerstoff medizinisch Messer Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN Concentration unit: % (V/V) percent vol

Sponsors

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
Secondary end point(s): Tolerability;Timepoint(s) of evaluation of this end point: on study day

Countries

Austria

Contacts

Public ContactUniv. Klinik f. Klin. Pharmakologie

Medizinische Universität Wien

klin-pharmakologie@meduniwien.ac.at+431404002981

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026