Chorda Tympani DisorderNCT04881513
The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery
A study testing Narrow Band Imaging, Tongue sensitivity testing and Qualitiy of life in people with Chorda Tympani Disorder and Taste Disorders, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chorda Tympani Disorder, Taste Disorders, Stapes Fixation
- What is being tested?
- Narrow Band Imaging, Tongue sensitivity testing and Qualitiy of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana
Ljubljana, 1000
Nina Božanić Urbančič, MD, 0038615224814, nina.bozanic@kclj.si
Saba Battelino, MD, PhD, 0038615224814, saba.battelino@kclj.si
About this study
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
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.
Read the 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
- Being tested
- Narrow Band Imaging, Tongue sensitivity testing, Qualitiy of life, Threshold change, Taste
- Keywords
- stapedectomy, taste, taste buds, chorda tympani, narrow band imaging, electrical stimulation, taste strips, two point discrimination, quality of life
- Medical subject headings
- Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow Band ImagingDiagnostic test
Also called NBI
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 testingDiagnostic test
Also called Two point discriminator
testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.
Qualitiy of lifeOther
Also called SF36
Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire
Threshold changeDiagnostic test
Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery
TasteDiagnostic test
Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Structure /function of the taste buds and QoL | Other | 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. Receives: Diagnostic Test: Narrow Band Imaging; Diagnostic Test: Tongue sensitivity testing; Other: Qualitiy of life; Diagnostic Test: Threshold change; Diagnostic Test: Taste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jan 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chorda Tympani DisorderStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Bozanic Urbancic, University Medical Centre Ljubljana
- Investigators
- Nina Božanić Urbančič, MD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881513
- Sponsor's protocol ID
- CHORDA_TASTE_OTOSCLEROSIS
- Status last verified
- Sep 2021
- First submitted
- 7 Jan 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04881513
- Acronym / sponsor ID
- CHORDA_TASTE_OTOSCLEROSIS
- Conditions
- Chorda Tympani Disorder, Taste Disorders, Stapes Fixation
- Keywords
- stapedectomy, taste, taste buds, chorda tympani, narrow band imaging, electrical stimulation, taste strips, two point discrimination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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: TasteThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow Band ImagingAlso: NBITesting 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 | Structure /function of the taste buds and QoL |
| Tongue sensitivity testingAlso: Two point discriminatortesting the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm. | Diagnostic test | Structure /function of the taste buds and QoL |
| Qualitiy of lifeAlso: SF36Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire | Other | Structure /function of the taste buds and QoL |
| Threshold changeMeasuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery | Diagnostic test | Structure /function of the taste buds and QoL |
| TasteTaste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery. | Diagnostic test | Structure /function of the taste buds and QoL |
Primary outcome
The change of the count of the taste buds after stapes surgery mesured by NBI
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Božanić Urbančič, MD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow Band Imaging, Tongue sensitivity testing and Qualitiy of life in people with Chorda Tympani Disorder and Taste Disorders, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Božanić Urbančič, MD (+38615224183, nina.bozanic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the count of the taste buds after stapes surgery mesured by NBI (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.