Standardization of a New Psychophysical Olfactory Test, T... | NCT06386523

Studies
Standardization of a New Psychophysical Olfactory Test, TODA2

NCT06386523

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Apr 22, 2025Actual

Enrollment

112Actual

Phase

Not Applicable

Conditions

Patients Without an Olfactory Disorder

Interventions

Passage of olfactory tests

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2024Actual

Primary Completion Date

Mar 25, 2025Actual

Completion Date

Mar 25, 2025Actual

First Submitted Date

Apr 19, 2024

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Passage of olfactory tests	Experimental	Passage of olfactory tests: TODA2 and Sniffin Stick Test	Diagnostic Test: Passage of olfactory tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Passage of olfactory tests	Diagnostic Test	test TODA2 and Sniffin Stick Test	Passage of olfactory tests

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clair VANDERSTEEN	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH de Cannes		Cannes			France
CHU de Nice

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided