The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery
NCT04881513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-09-30
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.
Conditions
- Chorda Tympani Disorder
- Taste Disorders
- Stapes Fixation
Interventions
- 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)
- DIAGNOSTIC_TEST
-
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
- DIAGNOSTIC_TEST
-
Taste
Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.
Sponsors & Collaborators
-
University Medical Centre Ljubljana
lead OTHER
Principal Investigators
-
Nina Božanić Urbančič, MD · UMC Ljubljana
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-01
- Primary Completion
- 2021-12-30
- Completion
- 2022-01-01
Countries
- Slovenia
Study Locations
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