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

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Patients Without an Olfactory Disorder

Treatments

Diagnostic Test: Passage of olfactory tests

Study type

Interventional

Funder types

Other

Identifiers

NCT06386523
23-AOI-03

Details and patient eligibility

About

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

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

112 participants in 1 patient group

Passage of olfactory tests
Experimental group
Description:
Passage of olfactory tests: TODA2 and Sniffin Stick Test
Treatment:
Diagnostic Test: Passage of olfactory tests

Trial contacts and locations

2

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Central trial contact

marion causeret; Clair VANDERSTEEN

Data sourced from clinicaltrials.gov

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