Self-assessment of Olfactory Disorders for French Speaking Patients (VIF-DOR)

Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

• Study Contact: Name: Marion RENAUD; Phone Number: +33 3 88 12 61 89; Email: Marion.renaud@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Les Hôpitaux Universitaires de Strasbourg
    • Contact: Marion RENAUD; Phone Number: +33 3 88 12 61 89; Email: Marion.renaud@chru-strasbourg.fr
    • Principal Investigator: Marion RENAUD
    • Sub-Investigator: Christian DEBRY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Case patients with acquired olfactory disorders will be selected from the ENT primary care clinic of Strasbourg University Hospital.

Control patient without olfactory disorders are treated for another ENT pathology in the ENT primary care clinic of Strasbourg University Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery.	Behavioral: Self-assessment of olfactory disorders through two questionnaires.; Assessment of sense of smell or loss of smell using an Analogue Visual Scale; Carrying out the objective smell test (Sniffin' sticks test) (gold standard); 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))
Control; Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell	Behavioral: Self-assessment of olfactory disorders through two questionnaires.; Assessment of sense of smell or loss of smell using an Analogue Visual Scale; Carrying out the objective smell test (Sniffin' sticks test) (gold standard); 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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Self-assessment; Olfactory disorders; Olfactory capacities
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; Anosmia
• Other Study ID Numbers: 7917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No