Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-28 @ 7:08 PM
Study NCT ID:
NCT04884893
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nitrous Oxide on EEG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slow wave activity', 'timeFrame': 'During nitrous oxide administration', 'description': 'Delta wave in EEG'}, {'measure': 'Slow wave activity', 'timeFrame': 'Following 20 minutes after nitrous oxide administration', 'description': 'Delta wave in EEG'}], 'secondaryOutcomes': [{'measure': 'Self-reported psychiatric symptoms', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Symptom Check List 90 (SCL-90) is a self-reported questionnaire measuring psychological stress. Results are normed, meaning that test scores can be compared to Finnish reference values. In this study we measure if there is an increase in self-reported psychiatric symptoms after nitrous oxide administration.'}, {'measure': 'Side effects - anxiety', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported anxiety on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - restlessness', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported restlessness on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - mood elevation', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported mood elevation on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - nausea', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported nausea on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - tension', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported tension on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - uneasiness', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported uneasiness on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - tiredness', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported tiredness on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - numbness', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported numbness on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - dizziness', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported dizziness on a 0 (no at all) to 5 (very much) scale'}, {'measure': 'Side effects - agitation', 'timeFrame': 'Baseline, 20 minutes after nitrous oxide', 'description': 'Self reported agitation on a 0 (no at all) to 5 (very much) scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG', 'Slow wave activity', 'Nitrous oxide', 'N-methyl-D-aspartate-receptor blockade', 'Delta wave', 'Self-reported psychiatric symptoms'], 'conditions': ['Nitrous Oxide', 'Electroencephalography', 'Anesthetic, Inhalation']}, 'descriptionModule': {'briefSummary': 'Our recent preclinical observations suggest that monitoring of slow electroencephalogram (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such as ketamine or nitrous oxide. In this project we will carry out critical clinical research on healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for the design of clinical trials on depressed individuals. The project will be done in collaboration between neuroscientists at the University of Helsinki and clinicians at the Tampere University Hospital.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "Females excluded due to higher risk of nausea and due to menstrual cycle's effect on EEG", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. informed consent obtained\n2. age between 18 - 40\n3. male\n4. body mass index 18 - 27\n\nExclusion Criteria:\n\n1. Age \\< 18 or \\> 40\n2. Alcohol Use Disorders Identification Test (AUDIT) \\>6 points\n3. Drug Abuse Screening Test 20 (DAST-20) \\> 0 points\n4. Beck Depression Inventory (BDI) \\> 11 points\n5. Symptom Check List 90 (SCL-90) over mean values of Finnish population in any dimensions of the SCL-90 or the global severity index\n6. Any respiratory disorder including sleep apnea\n7. Any heart illness\n8. Epilepsy\n9. Known vitamin B12 deficiency'}, 'identificationModule': {'nctId': 'NCT04884893', 'acronym': 'HUMANOID', 'briefTitle': 'Effect of Nitrous Oxide on EEG', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study', 'orgStudyIdInfo': {'id': 'R18097M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent nitrous oxide', 'description': '10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous nitrous oxide', 'description': '20 min 50% nitrous oxide + 20 min 100% oxygen', 'interventionNames': ['Drug: Nitrous Oxide']}], 'interventions': [{'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': '50% nitrous oxide', 'armGroupLabels': ['Continuous nitrous oxide', 'Intermittent nitrous oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Maija-Liisa Kalliomäki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}