Chronic Rhinosinusitis Clinical Trial
— VIF-DOROfficial title:
Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires
NCT number | NCT04705805 |
Other study ID # | 7917 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 22, 2021 |
Est. completion date | April 22, 2022 |
Verified date | April 2023 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. Some 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. Since 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.
Status | Completed |
Enrollment | 135 |
Est. completion date | April 22, 2022 |
Est. primary completion date | April 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient > 18 years old - Patient affiliated to a sickness insurance social protection scheme, beneficiary or rightful claimant - 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. - Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery (case group). - Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell (control group). Exclusion Criteria: - Patient in an emergency or life-threatening situation - Patient under judicial protection - Patient under guardianship or trusteeship - Inability to provide informed information to the patient (patient does not speak or understand French) - Patient with congenital syndromic or non-syndromic congenital anosmia |
Country | Name | City | State |
---|---|---|---|
France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reliability of the self-assessment questionnaire | 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. | 3 months |
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