Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-28 @ 5:10 PM
Study NCT ID:
NCT04050267
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2019-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low Concentrations of Nitrous Oxide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants go through all study arms, in random order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2019-05-15', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive test results', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).'}, {'measure': 'Reaction Time', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nitrous oxide', 'tracing gas', 'breathing experiments', 'cognitive tests'], 'conditions': ['Nitrous Oxide Poisoning']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human.', 'detailedDescription': 'Nitrous oxide is a widely used gas in medicine, in standard concentrations above 50%. Its favourable physical properties and easy detectability by anaesthetic gas analysors predispose nitrous oxide to become a possible "tracing gas" for leak detection in experiments in which modified breathing system are in use. In these breathing experiments, the inspired concentrations of nitrous oxide would be well below the anaesthetic/analgesic concentrations. The aim of this study is to investigate the effects of these low concentrations of nitrous oxide (5, 7, 10, 12, 15, 20 %), compared to placebo (air, 0% nitrous oxide). The cognitive functions are tested using Digit Symbol Substitution Test, Reaction Time and Visual Analogue Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers from the Czech Technical University\n\nExclusion Criteria:\n\n* pregnancy\n* allergy to nitrous oxide\n* severe asthma or other severe respiratory conditions\n* severe cardiovascular conditions'}, 'identificationModule': {'nctId': 'NCT04050267', 'briefTitle': 'Effects of Low Concentrations of Nitrous Oxide', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Effects of Low Concentrations of Nitrous Oxide on Cognitive Functions and Reaction Time', 'orgStudyIdInfo': {'id': 'VentRes-2019-02-KR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group - air', 'description': 'Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.', 'interventionNames': ['Other: Placebo - air']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 5% nitrous oxide', 'description': 'Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 7% nitrous oxide', 'description': 'Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 10% nitrous oxide', 'description': 'Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 12% nitrous oxide', 'description': 'Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 15% nitrous oxide', 'description': 'Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - 20% nitrous oxide', 'description': 'Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.', 'interventionNames': ['Drug: Nitrous Oxide']}], 'interventions': [{'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.', 'armGroupLabels': ['Intervention Group - 10% nitrous oxide', 'Intervention Group - 12% nitrous oxide', 'Intervention Group - 15% nitrous oxide', 'Intervention Group - 20% nitrous oxide', 'Intervention Group - 5% nitrous oxide', 'Intervention Group - 7% nitrous oxide']}, {'name': 'Placebo - air', 'type': 'OTHER', 'description': 'Breathing air with 21 % oxygen, no nitrous oxide.', 'armGroupLabels': ['Control group - air']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Czech Technical University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Karel Roubik, prof., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Czech Technical University in Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}