Standardization of a New Psychophysical Olfactory Test, TODA2

Not Applicable

Completed

• Conditions: Patients Without an Olfactory Disorder
• Interventions: Diagnostic Test: Passage of olfactory tests

• Registration Number: NCT06386523
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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

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 Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Study Start: 2024-10-21
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Passage of olfactory tests	Passage of olfactory tests	Passage of olfactory tests: TODA2 and Sniffin Stick Test

Primary Outcome Measures

Name	Time	Method
Passage of olfactory tests:	Day 7	TODA2

Secondary Outcome Measures

Name	Time	Method
Identify confounding factors, i.e. factors that can influence the results of the olfactory test	Day 0	Age of patients

Trial Locations

Locations (2)

CH de Cannes; 🇫🇷 Cannes, France

CHU de Nice; 🇫🇷 Nice, France