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

Primary Purpose

Chorda Tympani Disorder, Taste Disorders, Stapes Fixation

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Narrow Band Imaging
Tongue sensitivity testing
Qualitiy of life
Threshold change
Taste
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chorda Tympani Disorder focused on measuring stapedectomy, taste, taste buds, chorda tympani, narrow band imaging, electrical stimulation, taste strips, two point discrimination, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: otosclerosis surgery -

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

-

Sites / Locations

  • UMC LjubljanaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Structure /function of the taste buds and QoL

Arm Description

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.

Outcomes

Primary Outcome Measures

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 .
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.
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.
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
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)

Secondary Outcome Measures

Full Information

First Posted
January 7, 2021
Last Updated
September 29, 2021
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04881513
Brief Title
The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorda Tympani Disorder, Taste Disorders, Stapes Fixation
Keywords
stapedectomy, taste, taste buds, chorda tympani, narrow band imaging, electrical stimulation, taste strips, two point discrimination, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structure /function of the taste buds and QoL
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Narrow Band Imaging
Other Intervention Name(s)
NBI
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Tongue sensitivity testing
Other Intervention Name(s)
Two point discriminator
Intervention Description
testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.
Intervention Type
Other
Intervention Name(s)
Qualitiy of life
Other Intervention Name(s)
SF36
Intervention Description
Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire
Intervention Type
Diagnostic Test
Intervention Name(s)
Threshold change
Intervention Description
Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Taste
Intervention Description
Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.
Primary Outcome Measure Information:
Title
The change of the count of the taste buds after stapes surgery mesured by NBI
Description
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 .
Time Frame
2 years
Title
The change of the structure -blood vessel morphology of the taste buds after stapes surgery mesured by NBI
Description
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.
Time Frame
2 years
Title
The change of the function of the taste buds mesured by the test strips
Description
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.
Time Frame
2 years
Title
The influence of the chorda tympani intraoperative manipulation on the patients quality of life
Description
The patients quality of life is measured by the SF 36 questionnaire
Time Frame
2 years
Title
The change of the function of the chorda tympani nerve measured by the change of tongue sensitivity measured by two point discrimination test
Description
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)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: otosclerosis surgery - Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Božanić Urbančič, MD
Phone
+38615224183
Email
nina.bozanic@kclj.si
First Name & Middle Initial & Last Name or Official Title & Degree
Saba Battelino, MD. PhD
Phone
0038615224814
Email
saba.battelino@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Božanić Urbančič, MD
Organizational Affiliation
UMC Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Božanić Urbančič, MD
Phone
0038615224814
Email
nina.bozanic@kclj.si
First Name & Middle Initial & Last Name & Degree
Saba Battelino, MD, PhD
Phone
0038615224814
Email
saba.battelino@kclj.si
First Name & Middle Initial & Last Name & Degree
Nina Božanić Urbančič, MD
First Name & Middle Initial & Last Name & Degree
Saba Battelino, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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