Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT07237958
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects on the Olfactory Epithelium and the Olfactory Nerve From Exposure to Diesel Exhaust
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-17', 'size': 129337, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-18T15:48', 'hasProtocol': True}, {'date': '2021-06-17', 'size': 96751, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-18T15:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diesel exhaust causes cellular dysfunction of the olfactory system', 'timeFrame': '3 years.', 'description': 'RNA sequencing and DNA methylation will be conducted to identify biomarkers for acute exposure to diesel exhaust.'}], 'secondaryOutcomes': [{'measure': 'Cognitive test', 'timeFrame': '3 years', 'description': 'Olfactory function well be evaluated by using "sniffin\' sticks," and a Letter-Digit Substitution Test as a marker for cognitive processing speed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive function', 'Alzheimer Disease', 'Diesel Exhaust', 'Olfactory nerve'], 'conditions': ['Alzheimer Disease (AD)', 'Dementia Alzheimer Type', 'Air Pollution Exposure']}, 'referencesModule': {'references': [{'pmid': '35010571', 'type': 'BACKGROUND', 'citation': 'Martikainen MV, Aakko-Saksa P, van den Broek L, Cassee FR, Carare RO, Chew S, Dinnyes A, Giugno R, Kanninen KM, Malm T, Muala A, Nedergaard M, Oudin A, Oyola P, Pfeiffer TV, Ronkko T, Saarikoski S, Sandstrom T, Schins RPF, Topinka J, Yang M, Zeng X, Westerink RHS, Jalava PI. TUBE Project: Transport-Derived Ultrafines and the Brain Effects. Int J Environ Res Public Health. 2021 Dec 28;19(1):311. doi: 10.3390/ijerph19010311.'}], 'seeAlsoLinks': [{'url': 'https://www.alzheimer-europe.org/our-work/past-work/past-projects/adair?language_content_entity=en', 'label': 'ADAIR website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to study the effect exposure to air pollution and its effect on development of dementia.\n\nDoes the diesel exhaust change the function of the olfactory system?\n\nHave the exposures measurable effects on the sense of smell and cognitive ability?\n\nForty people are exposed to diesel exhaust exhaust and filtered air. The exposures are blinded and in a randomized order. Both groups undergo biopsies of the olfactory epithelium in the nose under local anesthesia after the exposures and after performing cognitive test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* non-smoker\n\nExclusion Criteria:\n\n* Allergic rhinitis\n* Asthma\n* Diabetes mellitus\n* Kidney or liver failure\n* Angina pectoris or previous ventricular arrhythmia\n* Systolic blood pressure \\>190 mmHg or \\<100 mmHg\n* Previous blood disease\n* Blood donation in the last three months prior to study start\n* Previous or ongoing tobacco smoking and exposure to air pollution in the workplace\n* Absence of informed consent'}, 'identificationModule': {'nctId': 'NCT07237958', 'acronym': 'DINOSE', 'briefTitle': 'Effects on the Olfactory Epithelium and the Olfactory Nerve From Exposure to Diesel Exhaust', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Effects on the Olfactory Epithelium in the Nose and the Olfactory Nerve (Nervus Olfactorius) From Exposure to Diesel Exhaust', 'orgStudyIdInfo': {'id': '2018-438-31'}, 'secondaryIdInfos': [{'id': 'x', 'type': 'OTHER_GRANT', 'domain': 'The Swedish Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exposure to diesel exhaust', 'description': 'The participants will be exposed in an exposure chamber for diesel exhaust in a concentration of 300 µg/m³ for one hour.', 'interventionNames': ['Other: Diesel Exhaust Particles']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exposure to filtered air', 'description': 'The participants will be exposed in an exposure chamber to filtered air for one hour.', 'interventionNames': ['Other: Filtered air']}], 'interventions': [{'name': 'Diesel Exhaust Particles', 'type': 'OTHER', 'description': 'During exposure to diesel exhaust, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale.', 'armGroupLabels': ['Exposure to diesel exhaust']}, {'name': 'Filtered air', 'type': 'OTHER', 'description': 'During exposure to filtered air, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale', 'armGroupLabels': ['Exposure to filtered air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå Univeristy', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Umeå', 'class': 'OTHER'}, {'name': 'University of Eastern Finland', 'class': 'OTHER'}, {'name': 'Czech Academy of Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ala Muala', 'investigatorAffiliation': 'Umeå University'}}}}