NCT04881513|Unknown

The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery

The Structure and the Function of the Taste Buds After the Stapes Surgery and the Patients Quality of Life and it's Correlation to the Change of the Threshold of the Chorda Tympani Electrical Stimulation

University Medical Centre Ljubljana ClinicalTrials.gov

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1 other identifier

CHORDA_TASTE_OTOSCLEROSIS

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMay 2021

StartedJan 2020

CompletionJan 2022

Brief Summary

Patients admitted for the otosclerosis operation are included in the study. The Narrow Band Imaging (NBI) of their taste buds is performed before the operation. The sensory function of the anterior 2/3 of the tongue is tested with the two point discrimination discs, the taste is tested with taste strips and the SF-36 questionnaire is applied. During the operation in local anesthesia the threshold for the tongue sensation (by the stimulation of the chorda tympani nerve) of the first 2/3 of the tongue at the beginning of the operation (when we first encounter the chorda tympani nerve) and at the end of the operation is measured.One month and six months after the operation the tests are being repeated (NBI, two-point discrimination and SF-36 questionnaire). The study has the National Ethical Committee approval.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

January 1, 2020

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed

4 months until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed

2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed

Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

January 7, 2021

Last Update Submit

September 29, 2021

Conditions

Chorda Tympani Disorder Taste Disorders Stapes Fixation

Keywords

stapedectomytastetaste budschorda tympaninarrow band imagingelectrical stimulationtaste stripstwo point discriminationquality of life

Outcome Measures

Primary Outcomes (5)

The change of the count of the taste buds after stapes surgery mesured by NBI
The evaluation of the influence of the manipulation of the chorda tympani nerve on the structure of the taste buds measured by Narrow Band Imaging technique prior to surgery and 1 month and 6 months after surgery. The number of the taste buds will be counted on the surface of 20 mm2 .
2 years
The change of the structure -blood vessel morphology of the taste buds after stapes surgery mesured by NBI
The evaluation of the influence of the manipulation of the chorda tympani nerve on the structure of the taste buds measured by Narrow Band Imaging technique prior to surgery and 1 month and 6 months after surgery. The blood vessel morphology will be assessed by the 5-point scoring system.
2 years
The change of the function of the taste buds mesured by the test strips
The evaluation of the influence of the chorda tympani intraoperative manipulation to the change of the chorda tympani function measured by the taste strips test.
2 years
The influence of the chorda tympani intraoperative manipulation on the patients quality of life
The patients quality of life is measured by the SF 36 questionnaire
2 years
The change of the function of the chorda tympani nerve measured by the change of tongue sensitivity measured by two point discrimination test
The evaluation of the influence of the chorda tympani intraoperative manipulation to the change of the chorda tympani function measured by the two pint dicrimination test ( in mm)
2 years

Study Arms (1)

Structure /function of the taste buds and QoL

OTHER

The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.

Diagnostic Test: Narrow Band ImagingDiagnostic Test: Tongue sensitivity testingOther: Qualitiy of lifeDiagnostic Test: Threshold changeDiagnostic Test: Taste

Interventions

Narrow Band ImagingDIAGNOSTIC_TEST

Testing the taste buds structure (blood vessels morphology- classified to 5 types) and the number of taste buds per 20mm2, by Narrow Band Imaging technique before and after the operation (one and six months)

Also known as: NBI