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

Taste Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881513
• Other study ID #: CHORDA_TASTE_OTOSCLEROSIS
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2021
• Source: University Medical Centre Ljubljana
• Contact: Nina Božanic Urbancic, MD
• Phone: +38615224183
• Email: nina.bozanic[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients admitted for otosclerosis operation 18 to 65 years old, not taking medications that could influence the taste and not having the problems with the smell are being recruited for the study.

The informed consent is signed by the patient. The Narrow Band Imaging (NBI) of their taste buds is performed before the operation. The number of taste buds in the 20mm2 size area and the blood vessel morphology is being recorded. For the blood vessel morphology the five point scoring system is used. Both sides of the tongue are tested separately.

The sensory function of the anterior 2/3 of the tongue is tested with the two point discrimination discs. Both sides of the tongue are tested separately.

The taste strips are used with 4 different concentrations of sweet, sour, salty and bitter applied to each side of the tongue separately.

SF-36 questionnaire adapted to Slovenian language is applied. During the operation in local anesthesia the threshold for the tongue sensation at the beginning of the operation (when the investigators first encounter the chorda tympani nerve) and at the end of the operation is measured. The investigators use the facial nerve monitoring system for the measurements and stimulate directly the chorda tympani with electrical current. After each operation the surgeon determines the grade of the intraoperative manipulation of the chorda tympani nerve.

One month and six months after the operation the tests are being repeated (NBI, two-point discrimination, taste testing with taste strips and SF-36 questionnaire).

The study has the National Ethical Committee approval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: otosclerosis surgery -

Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue

-

Related Conditions & MeSH terms

• Disease
• Taste Disorders

Intervention

Diagnostic Test:
• Narrow Band Imaging
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)
• Tongue sensitivity testing
testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.

Other:
• Qualitiy of life
Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire

Diagnostic Test:
• Threshold change
Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery
• Taste
Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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