Taste DisturbanceNCT01584011
Taste Disorders in Middle Ear Disease and After Middle Ear Surgery
An observational study of Taste Disturbance, run by Uppsala University at 1 site in Sweden.
Trial summary
Objectives To evaluate the impact of taste disturbance in different types of chronic middle ear diseases and after middle ear surgery. Hypothesis That patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Taste Disturbance
- What is being tested?
- taste measurement, Symptom questionnaire and Quality of life questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 310 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients planned for primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis
Who may be able to join
- Patients that undergoes primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis
Who cannot join
- Not primary surgery
- Not able to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Vastmanlands sjukhus ENT department
Västerås, 72189
Katarina Berling, MD, +46735303045, katarina.berling@spray.se
Magnus vonUnge, PhD, Professor, +46733849463, magnusvu@hotmail.com
About this study
Objectives
To evaluate the impact of taste disturbance in different types of chronic middle ear diseases and after middle ear surgery.
Read more
Hypothesis
That patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease.
That patients with otosclerosis, has a normal nerve function before surgery.
That patients with normal taste before surgery are more likely to notices a taste disturbance.
That nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve.
Methods
A clinical study has been launched that measures taste function with two different methods for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before and after middle ear surgery in patients operated with middle ear surgery because of otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120 patients in this study.
A parallel study of the patients own experience of the symptom has also been launched were the patients answer a questionary and a quality of life document. The investigators plan to include 300 patients in this study.
A histological study where specimens of CTN from healthy ears and from ears with chronic disease will be investigated with electron microscopy has also started.
Read the detailed description
Taste sensations are provided by three different nerves of which the chorda tympani nerve (CTN) is the major taste nerve. It innervates taste buds in the two anterior thirds of the tongue. The CTN location in the middle ear predisposes for trauma of the nerve. In various forms of middle ear pathology, such as chronic otitis and cholesteatoma the nerve can be affected by the pathologic process per se, since the nerve may become exposed to bacteria toxins, enzymes or mechanical damage. During middle ear surgery, it can be cut off, stretched, touched or dried out by the heat of the microscope light beam. The nerve function in these situations is not clarified. Is it for example better to cut the nerve than to leave it traumatized after surgery. Therefore previous reports on objective CTN function pre- and postoperatively unfortunate suffer from inadequate descriptions of ear disease that were studied. In order to elucidate these questions and to give the surgeon deeper knowledge about how to handle CTN during surgery a prospective study is initiated on patients to be operated on with primary middle ear surgery.
We believe that patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease, and that patients with otosclerosis has a normal nerve function before surgery. We also believe that patients with normal taste before surgery are more likely to notice a taste disturbance and that a nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve. Two methods of taste measuring are used in the study, Electrogustometry (EGM) and a Filter Paper Disc method (FPD). We have evaluated EGM regarding possible bias and artifacts as well as the correlation regarding results from the two methods.
The study contains three substudies or arms.
- A clinical prospective trial where 100 patients that undergoes primary middle ear surgery because of chronic otitis, cholesteatoma or otosclerosis are evaluated with EGM and FPD before and after surgery. They also answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
- A clinical multi center study on 200 patients that undergoes primary surgery because of otosclerosis. These patients answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
- A histological study with electron microscopy of CTN from healthy ears and from ears whit chronic otitis or cholesteatoma. We we plan to investigate samples from five healthy and from five sick ears with EM.
- Conditions
- Taste Disturbance
- Being tested
- taste measurement, Symptom questionnaire, Quality of life questionnaire, Nerve sample
- Keywords
- Taste, Chorda tympani nerve
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taste measurementOther
Taste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery
Symptom questionnaireOther
Answering a symptom questionnaire before and after surgery until one year after surgery
Quality of life questionnaireBehavioural
Answering a quality of life questionnaire before and one year after surgery
Nerve sampleOther
Collect nerve samples from patients undergoing surgery because of vestibular schwannoma, chronic otitis media or cholesteatoma where the nerve cant be saved during planned operation.
| Study group | Role | What they receive |
|---|---|---|
| Middle ear disease | Not described Receives: Other: taste measurement; Other: Symptom questionnaire; Behavioral: Quality of life questionnaire; Other: Nerve sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste disturbance
Taste disturbance postoperative will be measured with electrogustometry, filter paper disc methode and symptom questionnaire before surgery and at four times after surgery up till one year poatoperative.
Measured: One year postoperative
Secondary outcomes (2)
Quality of life
A quality of life evaluation will be performed before surgery and one year after surgery.
Measured: one year
Histopathological changes
Electron microscopy investigation of specimen from healthy ears and from ears with chronic otitis media or cholesteatoma were the nerve could not be saved during the operation.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste DisturbanceStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarina Berling, MD, Principal investigator, 1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584011
- Sponsor's protocol ID
- CTN1
- Other IDs
- CTN12
- Status last verified
- Apr 2012
- First submitted
- 20 Apr 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Disorders in Middle Ear Disease and After Middle Ear Surgery
- ClinicalTrials.gov ID
- NCT01584011
- Acronym / sponsor ID
- CTN1
- Conditions
- Taste Disturbance
- Keywords
- Taste, Chorda tympani nerve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
Objectives
To evaluate the impact of taste disturbance in different types of chronic middle ear diseases and after middle ear surgery.
Hypothesis
That patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease.
That patients with otosclerosis, has a normal nerve function before surgery.
That patients with normal taste before surgery are more likely to notices a taste disturbance.
That nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve.
Methods
A clinical study has been launched that measures taste function with two different methods for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before and after middle ear surgery in patients operated with middle ear surgery because of otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120 patients in this study.
A parallel study of the patients own experience of the symptom has also been launched were the patients answer a questionary and a quality of life document. The investigators plan to include 300 patients in this study.
A histological study where specimens of CTN from healthy ears and from ears with chronic disease will be investigated with electron microscopy has also started.
Detailed description
Taste sensations are provided by three different nerves of which the chorda tympani nerve (CTN) is the major taste nerve. It innervates taste buds in the two anterior thirds of the tongue. The CTN location in the middle ear predisposes for trauma of the nerve. In various forms of middle ear pathology, such as chronic otitis and cholesteatoma the nerve can be affected by the pathologic process per se, since the nerve may become exposed to bacteria toxins, enzymes or mechanical damage. During middle ear surgery, it can be cut off, stretched, touched or dried out by the heat of the microscope light beam. The nerve function in these situations is not clarified. Is it for example better to cut the nerve than to leave it traumatized after surgery. Therefore previous reports on objective CTN function pre- and postoperatively unfortunate suffer from inadequate descriptions of ear disease that were studied. In order to elucidate these questions and to give the surgeon deeper knowledge about how to handle CTN during surgery a prospective study is initiated on patients to be operated on with primary middle ear surgery.
We believe that patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease, and that patients with otosclerosis has a normal nerve function before surgery. We also believe that patients with normal taste before surgery are more likely to notice a taste disturbance and that a nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve. Two methods of taste measuring are used in the study, Electrogustometry (EGM) and a Filter Paper Disc method (FPD). We have evaluated EGM regarding possible bias and artifacts as well as the correlation regarding results from the two methods.
The study contains three substudies or arms.
- A clinical prospective trial where 100 patients that undergoes primary middle ear surgery because of chronic otitis, cholesteatoma or otosclerosis are evaluated with EGM and FPD before and after surgery. They also answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
- A clinical multi center study on 200 patients that undergoes primary surgery because of otosclerosis. These patients answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
- A histological study with electron microscopy of CTN from healthy ears and from ears whit chronic otitis or cholesteatoma. We we plan to investigate samples from five healthy and from five sick ears with EM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle ear disease | – | Other: taste measurement, Other: Symptom questionnaire, Behavioral: Quality of life questionnaire, Other: Nerve sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned for primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis
Key inclusion criteria (1 listed)
- Patients that undergoes primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis
Key exclusion criteria (2 listed)
- Not primary surgery
- Not able to participate
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 |
|---|---|---|
| taste measurementTaste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery | Other | Middle ear disease |
| Symptom questionnaireAnswering a symptom questionnaire before and after surgery until one year after surgery | Other | Middle ear disease |
| Quality of life questionnaireAnswering a quality of life questionnaire before and one year after surgery | Behavioural | Middle ear disease |
| Nerve sampleCollect nerve samples from patients undergoing surgery because of vestibular schwannoma, chronic otitis media or cholesteatoma where the nerve cant be saved during planned operation. | Other | Middle ear disease |
Primary outcome
Taste disturbance
Time frame: One year postoperative
Taste disturbance postoperative will be measured with electrogustometry, filter paper disc methode and symptom questionnaire before surgery and at four times after surgery up till one year poatoperative.
2 secondary outcomes
Quality of life
Time frame: one year
Histopathological changes
Time frame: At the time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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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.
Katarina Berling, MD principal investigator
1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Taste Disturbance, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 2 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 8 May 2012. 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 Sweden. 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 Katarina Berling, MD (+46735303045, katarina.berling@spray.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste disturbance (time frame: One year postoperative). 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 8 May 2012.