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OpenTrials
Completed

NCT Number: NCT04705805

Self-assessment of Olfactory Disorders for French Speaking Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-assessment of olfactory disorders through two questionnaires.

Behavioral
  • 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))

Primary outcomes

  1. Reliability of the self-assessment questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: VIF-DOR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2021
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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