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
| Registry | NCT04881513 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 50 (Estimated) |
| Sponsor | University Medical Centre Ljubljana (Other) |
| Conditions | Chorda Tympani Disorder, Taste Disorders, Stapes Fixation |
| Interventions | Narrow Band Imaging, Tongue sensitivity testing, Qualitiy of life, Threshold change, Taste (Diagnostic test, other) |
| Dates | start 2020-01-01, primary completion 2021-12-30 (estimated), completion 2022-01-01 (estimated), first posted 2021-05-11, last updated 2021-09-30 |
| Locations | 1 site in Slovenia |
Related Papers Related Patents Related Grants Related Experts
All trials for Chorda Tympani Disorder All trials for Taste Disorders All trials of Narrow Band Imaging All trials of Tongue sensitivity testing
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Structure /function of the taste buds and QoL | Other | Diagnostic Test: Narrow Band Imaging; Diagnostic Test: Tongue sensitivity testing; Other: Qualitiy of life; Diagnostic Test: Threshold change; Diagnostic Test: Taste | 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. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: otosclerosis surgery - Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue \-
| Facility | City | Country | Status |
|---|---|---|---|
| UMC Ljubljana | Ljubljana | Slovenia | Recruiting |