Patients Without an Olfactory DisorderTODA-STARNCT06386523
Standardization of a New Psychophysical Olfactory Test, TODA2
A study testing Passage of olfactory tests in people with Patients Without an Olfactory Disorder, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder: Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patients Without an Olfactory Disorder
- What is being tested?
- Passage of olfactory tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Oct 2024to 25 Mar 2025
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > 18 years old
- No olfactory complaints; subjective estimation of "normal" olfaction
- Affiliated to the Social Security system
- Signing of informed consent
Who cannot join
- Parosmia/phantosmia, hyposmia/anosmia, pre-existing subjective dysgeusia/ageusia
- ATCD of sinus or cranial neoplasia
- ATCD of sinus or cranial radiotherapy
- Neurological or neurodegenerative disease
- ATCD of persistent post-viral hyposmia or anosmia (including COVID) (more than 3 months)
Trial locations and contacts
2 sites in 1 country.
About this study
Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:
Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st
Read the detailed description
Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder (otosclerosis, pre- surgery, tonsillectomy, cosmetic surgery)
Data collection methods: 2 parts (duration approximately 1.5 hours) and for 30 volunteer patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st:
- Interview and clinical examination
- Passage of olfactory tests: TODA2 and Sniffin Stick Test in unirhinal
- On a voluntary basis, and within a limit of 30 patients, those who agree to come back a second time will be able to benefit from a second pass of the TODA2 on Day 7.
- Conditions
- Patients Without an Olfactory Disorder
- Being tested
- Passage of olfactory tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passage of olfactory testsDiagnostic test
test TODA2 and Sniffin Stick Test
| Study group | Role | What they receive |
|---|---|---|
| Passage of olfactory tests | Experimental | Passage of olfactory tests: TODA2 and Sniffin Stick Test Receives: Diagnostic Test: Passage of olfactory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passage of olfactory tests:
TODA2
Measured: Day 0
Passage of olfactory tests:
Sniffin Stick Test
Measured: Day 0
Passage of olfactory tests:
TODA2
Measured: Day 7
Secondary outcomes (2)
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
gender of patients
Measured: Day 0
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
Age of patients
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start21 Oct 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Without an Olfactory DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clair VANDERSTEEN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386523
- Sponsor's protocol ID
- 23-AOI-03
- Acronym
- TODA-STAR
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of a New Psychophysical Olfactory Test, TODA2
- ClinicalTrials.gov ID
- NCT06386523
- Acronym / sponsor ID
- TODA-STAR / 23-AOI-03
- Conditions
- Patients Without an Olfactory Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 26 Apr 2024 (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.
Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:
Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st
Detailed description
Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder (otosclerosis, pre- surgery, tonsillectomy, cosmetic surgery)
Data collection methods: 2 parts (duration approximately 1.5 hours) and for 30 volunteer patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st:
- Interview and clinical examination
- Passage of olfactory tests: TODA2 and Sniffin Stick Test in unirhinal
- On a voluntary basis, and within a limit of 30 patients, those who agree to come back a second time will be able to benefit from a second pass of the TODA2 on Day 7.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passage of olfactory tests | Experimental | Diagnostic Test: Passage of olfactory testsPassage of olfactory tests: TODA2 and Sniffin Stick Test |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects > 18 years old
- No olfactory complaints; subjective estimation of "normal" olfaction
- Affiliated to the Social Security system
- Signing of informed consent
Key exclusion criteria (5 listed)
- Parosmia/phantosmia, hyposmia/anosmia, pre-existing subjective dysgeusia/ageusia
- ATCD of sinus or cranial neoplasia
- ATCD of sinus or cranial radiotherapy
- Neurological or neurodegenerative disease
- ATCD of persistent post-viral hyposmia or anosmia (including COVID) (more than 3 months)
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 |
|---|---|---|
| Passage of olfactory teststest TODA2 and Sniffin Stick Test | Diagnostic test | Passage of olfactory tests |
Primary outcome
Passage of olfactory tests:
Time frame: Day 0
TODA2
Passage of olfactory tests:
Time frame: Day 0
Sniffin Stick Test
Passage of olfactory tests:
Time frame: Day 7
TODA2
2 secondary outcomes
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
Time frame: Day 0
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
Time frame: Day 0
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 22 Apr 2025.
- Individual participant dataSharing planned: No
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.
Clair VANDERSTEEN principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passage of olfactory tests in people with Patients Without an Olfactory Disorder, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 4 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 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Passage of olfactory tests: (time frame: Day 0). The study lists 3 primary outcomes in all. 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 22 Apr 2025.