Post-viral AnosmiaVIF-DORNCT04705805
Self-assessment of Olfactory Disorders for French Speaking Patients
An observational study of Post-viral Anosmia and Post-traumatic Anosmia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-viral Anosmia, Post-traumatic Anosmia, Chronic Rhinosinusitis
- What is being tested?
- Self-assessment of olfactory disorders through two questionnaires.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2021to 22 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Post-viral Anosmia, Post-traumatic Anosmia, Chronic Rhinosinusitis, Idiopathic Anosmia, Age-related Loss of Smell
- Being tested
- Self-assessment of olfactory disorders through two questionnaires.
- Keywords
- Olfactory disorders, Self-assessment, Quality of life, Olfactory capacities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assessment of olfactory disorders through two questionnaires.Behavioural
- 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))
| Study group | Role | What they receive |
|---|---|---|
| Case | Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery. Receives: Behavioral: Self-assessment of olfactory disorders through two questionnaires. | |
| Control | Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell Receives: Behavioral: Self-assessment of olfactory disorders through two questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start22 Jan 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-viral AnosmiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705805
- Sponsor's protocol ID
- 7917
- Acronym
- VIF-DOR
- Status last verified
- Apr 2023
- First submitted
- 8 Jan 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04705805
- Acronym / sponsor ID
- VIF-DOR / 7917
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Behavioral: 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 | – | Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)) | Behavioural | Case, Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-viral Anosmia and Post-traumatic Anosmia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the self-assessment questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.