Clinical trial NCT04705805: Self-assessment of Olfactory Disorders for French Speaking Patients
Official title: Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-viral Anosmia
Post-traumatic Anosmia
Chronic Rhinosinusitis
Idiopathic Anosmia
Age-related Loss of Smell
Keywords: Olfactory disorders
Self-assessment
Quality of life
Olfactory capacities
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reliability of the self-assessment questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References: