NCT04881513

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chorda Tympani Disorder
• Taste Disorders
• Stapes Fixation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-30
• Completion: 2022-01-01
• First posted: 2021-05-11
• Last updated: 2021-09-30

Locations

1 site across 1 country: Slovenia