Prospective Registery of Smell/Taste Clinic Ear/Nose/Throat | NCT06456008

Studies
Prospective Registery of Smell/Taste Clinic Ear/Nose/Throat

NCT06456008

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Olfactory Disorder
Taste Disorders
Smell Dysfunction
Smell Disorder

Interventions

Standard of care

Countries

Belgium

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2022Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Dec 31, 2035Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 6, 2024

First Posted Date

Jun 13, 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

Dec 9, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Smell/taste disorders are common conditions with a significant impact on quality of life. In September 2021, a specific consultation for patients with smell and taste disorders was initiated at the ENT-HNS (ear, nose, and throat, head and neck surgery) department of UZ Leuven, partly in light of post-COVID-19 related smell disorders.

With this observational ambidirectional study, the investigators aim to better map smell/taste disorders in the Belgian/Flemish population. Using standard-of-care diagnostic tests and structured questionnaires, the investigators strive to gain more insight into the severity, impact, and progression/prognosis of smell/taste disorders.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Standard of care	Other	Standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chemosensory function		Observational up to 5 years follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

The psychophysical testing as well as the questionnaires require a cooperative participant who can understand and follow instructions and communicate their choices.
Informed consent is necessary upon participation for prospective registry.

There are no exclusion criteria related to sex, gender, or ethnicity. There are no exclusion criteria related to medical history or prior treatments.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients consulting for chemosensory dysfunction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marnick Clijsters	Contact	003216348044		marnick.clijsters@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ/KU Leuven	Recruiting	Leuven	Vlaams-Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D013651	Taste Disorders
D000857	Olfaction Disorders

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided