Self-assessment of Olfactory Disorders for French Speaking Patients

Completed

• Conditions: Post-viral Anosmia; Age-related Loss of Smell; Post-traumatic Anosmia; Chronic Rhinosinusitis; Idiopathic Anosmia
• Interventions: Behavioral: Self-assessment of olfactory disorders through two questionnaires.

• Registration Number: NCT04705805
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Study Start: 2021-01-22
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Self-assessment of olfactory disorders through two questionnaires.	Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery.
Control	Self-assessment of olfactory disorders through two questionnaires.	Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell

Primary Outcome Measures

Name	Time	Method
Reliability of the self-assessment questionnaire	3 months	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.

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France