Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 7:58 AM
Study NCT ID:
NCT05539560
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}], 'ancestors': [{'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094562', 'term': 'Olfactory Training'}, {'id': 'D009822', 'term': 'Oils, Volatile'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 253545, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-09-09T10:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Extended Sniffin' Sticks Test score", 'timeFrame': '3 months follow-up', 'description': "Change in TDI score measured by Burghart Extended Sniffin' Sticks Test (TDI test). The TDI test, consists of a threshold test, a discrimination test, and an identification test. The results of the three subtests makes a total TDI score, where the minimum score is 1 and the maximum score is 48. A score \\>30 indicates normal olfactory function, a score between 15-30 indicates hyposmia and a score \\<15 indicates anosmia in the form of severely impaired or complete loss of olfaction."}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': '3 months follow-up', 'description': 'Change in Quality of Life measured by the questionnaire Taste and Smell Tool for Evaluation. The minimum score is 21 and the maximum score is 105. A higher score means worse outcome (quality of life).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Olfactory training', 'Quality of life', 'Olfactory dysfunction', 'Covid-19', 'Parosmia'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '40371997', 'type': 'DERIVED', 'citation': 'Mogensen DG, Aanaes K, Andersen IB, Jarden M, Backer V. Effect of Olfactory Training in COVID-19 Related Olfactory Dysfunction-A Placebo-Controlled Trial. Laryngoscope. 2025 May 15. doi: 10.1002/lary.32275. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "Aim: The aim is to investigate the effect of olfactory training with essential oils versus olfactory training with placebo-oils in patients with COVID-19 induced olfactory dysfunction\n\nStudy design: The study is a placebo-controlled randomized clinical trial with an intervention group and a control group. The intervention group receive four essential oils with scents of orange, lavender, clove, and peppermint. Patients in the control group receive a fragrance kit, consisting of the same containers, but with fragrance-free oils added. Both groups are instructed to smell each of the four oils for 30 seconds in the morning and evening, over a three-month intervention period. Patients are given a diary in which to record their olfactory training. The nurse or medical student instructing the patients in the training and performing the smell and taste tests is blinded.\n\nStudy population: Patients referred to the Unit for Sense of Taste and Smell in the Department of Otorhinolaryngology Head \\& Neck and Audiology at Rigshospitalet.\n\nInclusion criteria:\n\n* Impaired sense of taste and smell following COVID-19 \\> 3 months\n* Hyposmia (16.25-30.5) or anosmia (\\<16) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell with or without parosmia based on medical history\n* \\> 18 years of age\n\nExclusion criteria:\n\n* Cause of hyposmia, anosmia or parosmia other than COVID-19\n* Does not read or speak Danish\n* Lack of compliance to perform daily olfactory training\n\nProcedures:\n\n\\- TDI-test: To assess patients' sense of smell, the TDI-test with Sniffin' Sticks is used, which is a validated tool with normative data.\n\nQuestionnaires:\n\n\\- 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Olfactory dysfunction caused by COVID-19\n* Hyposmia (16.25-30.5) or anosmia (\\<16) with or without parosmia assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* Cause of hyposmia, anosmia or parosmia other than COVID-19\n* Does not read or speak Danish\n* Lack of compliance to perform daily olfactory training'}, 'identificationModule': {'nctId': 'NCT05539560', 'acronym': 'SMELLT2022', 'briefTitle': 'The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2022-ENT-1-olfactory'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Olfactory training twice a day with essential oils', 'interventionNames': ['Other: Olfactory training with essential oils']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Olfactory training twice a day with fragrance-free oils', 'interventionNames': ['Other: Olfactory training with fragrance-free oils']}], 'interventions': [{'name': 'Olfactory training with essential oils', 'type': 'OTHER', 'otherNames': ['Urtegaarden ApS Essential Oils'], 'description': 'Olfactory training twice daily with essential oils from Urtegaarden Aps with scents of orange, lavender, clove and peppermint. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.', 'armGroupLabels': ['Intervention group']}, {'name': 'Olfactory training with fragrance-free oils', 'type': 'OTHER', 'otherNames': ['Urtegaarden ApS Essential Oils (Fragrance-free custom made)'], 'description': 'Olfactory training twice daily with fragrance-free oils from Urtegaarden Aps in the same four containers as the intervention group. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ditte Gertz Mogensen, PhD-student', 'role': 'CONTACT', 'email': 'ditte.gertz.mogensen@regionh.dk', 'phone': '+45 35457508'}, {'name': 'Vibeke Backer, Professor', 'role': 'CONTACT', 'email': 'nina.vibeke.backer@regionh.dk', 'phone': '+45 3545 6033'}], 'facility': 'Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Ditte G Gertz Mogensen, PhD-student', 'role': 'CONTACT', 'email': 'ditte.gertz.mogensen@regionh.dk', 'phone': '+45 35457508'}, {'name': 'Vibeke Backer, Professor', 'role': 'CONTACT', 'email': 'nina.vibeke.backer@regionh.dk', 'phone': '+45 35456033'}], 'overallOfficials': [{'name': 'Vibeke G Backer, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ditte Gertz Mogensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD-student', 'investigatorFullName': 'Ditte Gertz Mogensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}