Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04705805
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-assessment of Olfactory Disorders for French Speaking Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the self-assessment questionnaire', 'timeFrame': '3 months', 'description': 'To assess the reliability of the self-assessment questionnaire of his olfactory capacities (Self-MOQ) in French in patients presenting an olfactory dysfunction of any acquired etiology for more than 3 months using a test-retest trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Olfactory disorders', 'Self-assessment', 'Quality of life', 'Olfactory capacities'], 'conditions': ['Post-viral Anosmia', 'Post-traumatic Anosmia', 'Chronic Rhinosinusitis', 'Idiopathic Anosmia', 'Age-related Loss of Smell']}, 'descriptionModule': {'briefSummary': 'Sense of smell disorders are common and are said to affect up to 20% of the general population. They are often disabling and have a real impact on the quality of life. Smell disorders are most often assessed using a visual analogue scale and more rarely with objective tests (Sniffing Stick Test). Many ENT units do not have these objective tests because they are time-consuming and are not covered by health insurance.\n\nSome teams, such as that of Dr Thomas Hummel of the Carl Gustav Carus University Clinic in Dresden Germany, have developed self-assessment questionnaires for the sense of smell in order to improve the overall care of patients with olfactory disorders. Two of these self-questionnaires seem to us to be particularly relevant for use in everyday practice.\n\nSince then, these questionnaires have already been validated in different languages (English, Chinese, Korean...), but have never been translated and validated in French. Translating and validating these questionnaires into French would make it possible to improve the management and follow-up of French patients with olfactory disorders and to assess the impact of loss of smell on their quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Case patients with acquired olfactory disorders will be selected from the ENT primary care clinic of Strasbourg University Hospital.\n\nControl patient without olfactory disorders are treated for another ENT pathology in the ENT primary care clinic of Strasbourg University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 18 years old\n* Patient affiliated to a sickness insurance social protection scheme, beneficiary or rightful claimant\n* Patient who has not expressed his or her opposition to the collection and processing of his or her data for research purposes after the investigator has provided informed information.\n* Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery (case group).\n* Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell (control group).\n\nExclusion Criteria:\n\n* Patient in an emergency or life-threatening situation\n* Patient under judicial protection\n* Patient under guardianship or trusteeship\n* Inability to provide informed information to the patient (patient does not speak or understand French)\n* Patient with congenital syndromic or non-syndromic congenital anosmia'}, 'identificationModule': {'nctId': 'NCT04705805', 'acronym': 'VIF-DOR', 'briefTitle': 'Self-assessment of Olfactory Disorders for French Speaking Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires', 'orgStudyIdInfo': {'id': '7917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery.', 'interventionNames': ['Behavioral: Self-assessment of olfactory disorders through two questionnaires.']}, {'label': 'Control', 'description': 'Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell', 'interventionNames': ['Behavioral: Self-assessment of olfactory disorders through two questionnaires.']}], 'interventions': [{'name': 'Self-assessment of olfactory disorders through two questionnaires.', 'type': 'BEHAVIORAL', 'description': "* Assessment of sense of smell or loss of smell using an Analogue Visual Scale\n* Carrying out the objective smell test (Sniffin' sticks test) (gold standard)\n* Information from two self-questionnaires translated into French: a quality of life questionnaire (The Questionnaire Olfactory Disorders (QOD)) and a self-assessment questionnaire of his olfactory capacities (Self-Mini Olfactory Questionnaire (Self-MOQ))", 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}