Standardization of a New Psychophysical Olfactory Test, TODA2 (TODA-STAR)

April 17, 2025 updated by: Centre Hospitalier Universitaire de Nice

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Interview and clinical examination
  2. Passage of olfactory tests: TODA2 and Sniffin Stick Test in unirhinal
  3. 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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cannes, France
        • CH de Cannes
      • Nice, France
        • Chu de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects > 18 years old
  • No olfactory complaints; subjective estimation of "normal" olfaction
  • Affiliated to the Social Security system
  • Signing of informed consent

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Passage of olfactory tests
Passage of olfactory tests: TODA2 and Sniffin Stick Test
Diagnostic test: Passage of olfactory tests
test TODA2 and Sniffin Stick Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passage of olfactory tests:
Time Frame: Day 0
TODA2
Day 0
Passage of olfactory tests:
Time Frame: Day 0
Sniffin Stick Test
Day 0
Passage of olfactory tests:
Time Frame: Day 7
TODA2
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
Time Frame: Day 0
gender of patients
Day 0
Identify confounding factors, i.e. factors that can influence the results of the olfactory test
Time Frame: Day 0
Age of patients
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Clair VANDERSTEEN, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 23-AOI-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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