Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-29 @ 9:59 AM
Study NCT ID:
NCT05562050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of the Anosmic Olfactory Mucosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological evaluation', 'timeFrame': '2023-2024', 'description': 'density'}, {'measure': 'Immunohistochemical evaluation', 'timeFrame': '2023-2024', 'description': 'density'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anosmia', 'COVID-19', 'Head Injury']}, 'descriptionModule': {'briefSummary': 'The present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to COVID-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. In order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'recruited from the clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Legally competent to vouch for their own study participation.\n* Informed and written consent for participation in this study.\n* Study group 1 (Post-COVID anosmia)\n\n 1. Diagnosed with persistent anosmia for approximately two years concurring with positive SARS-CoV-2 PCR-test between 2019 and 2020.\n 2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16\n 3. Between 25 and 35 years of age.\n\nStudy group 2 (Post-trauma anosmia)\n\n1. Diagnosed with persistent anosmia for approximately two years concurring with head trauma.\n2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16\n3. Between 25 and 35 years of age.\n\nStudy group 3 (Controls):\n\n1. Between 25 and 35 years of age.\n2. Undergoing reposition of a nasal fracture in general anaesthesia\n\nExclusion Criteria:\n\n* \\<25 years of age.\n* \\>35 years of age.\n* Chronic rhinosinusitis with/without polyps.\n* Nasal cancer.\n* Presence of viral or bacterial rhinosinusitis.\n* Uncontrolled allergic rhinosinusitis.\n* Coagulation deficiencies, e.g. haemophilia.\n* Use of anticoagulants.\n* Not able to undergo general anaesthesia.\n* Pregnancy.\n* Any use of nasal detumescence drugs ≤2 weeks before biopsy.\n* Any use of nasal steroids ≤3 months before biopsy.\n* Use of nasal inhaled recreational drugs ≤3 month before biopsy.\n* Participants not able to communicate in Danish or English.\n* Major Depression Inventory (MDI) score ≥27 \\[49, 50\\]\n* Mini Mental State Examination (MMSE) score ≤ 26 \\[51\\]\n* Study group 1 (Post-COVID anosmia)\n\n 1. Anosmia for less than two years or more than two and a half years.\n 2. No positive SARS-CoV-2 PCR-test concurring with olfactory dysfunction.\n 3. History of olfactory dysfunction before COVID-19 infection.\n* Study group 2 (Post-trauma anosmia)\n\n 1. Anosmia for less than two years or more than approximately two-three years.\n 2. Anosmia without concurring with head trauma\n 3. History of prior olfactory dysfunction before head trauma.\n* Study group 3 (Controls) 1. Known olfactory dysfunction."}, 'identificationModule': {'nctId': 'NCT05562050', 'briefTitle': 'Characteristics of the Anosmic Olfactory Mucosa', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital West Jutland'}, 'officialTitle': 'Characteristics of the Anosmic Olfactory Mucosa', 'orgStudyIdInfo': {'id': '1-10-72-106-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control'}, {'label': 'COVID-19 related anosmia'}, {'label': 'Head-trauma related anosmia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herning', 'country': 'Denmark', 'facility': 'ENT department', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Therese Ovesen, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Hospital Gødstrup'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicolai Nielsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Nicolai Nielsen', 'investigatorAffiliation': 'Regional Hospital West Jutland'}}}}