Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01584011
First received: April 20, 2012
Last updated: May 7, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Taste Disturbance
Other: taste measurement
Other: Symptom questionnaire
Behavioral: Quality of life questionnaire
Other: Nerve sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Taste disturbance [ Time Frame: One year postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    A quality of life evaluation will be performed before surgery and one year after surgery.

  • Histopathological changes [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Samples of nerve tissue


Estimated Enrollment: 310
Study Start Date: January 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Middle ear disease Other: taste measurement
Taste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery
Other: Symptom questionnaire
Answering a symptom questionnaire before and after surgery until one year after surgery
Behavioral: Quality of life questionnaire
Answering a quality of life questionnaire before and one year after surgery
Other: Nerve sample
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.

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.

  1. 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.
  2. 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.
  3. 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients planned for primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis

Criteria

Inclusion Criteria:

  • Patients that undergoes primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis

Exclusion Criteria:

  • Not primary surgery
  • Not able to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584011

Contacts
Contact: Katarina Berling, MD +46735303045 katarina.berling@spray.se
Contact: Magnus vonUnge, PhD, Professor +46733849463 magnusvu@hotmail.com

Locations
Sweden
Vastmanlands sjukhus ENT department Recruiting
Vasteras, Sweden, 72189
Contact: Katarina Berling, MD    +46735303045    katarina.berling@spray.se   
Contact: Magnus vonUnge, PhD, Professor    +46733849463    magnusvu@hotmail.com   
Principal Investigator: Katarina Berling, MD         
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Katarina Berling, MD 1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01584011     History of Changes
Other Study ID Numbers: CTN1, CTN12
Study First Received: April 20, 2012
Last Updated: May 7, 2012
Health Authority: Regionala etikprövningsnämnden Uppsala Sweden':'

Keywords provided by Uppsala University:
Taste
Chorda tympani nerve

Additional relevant MeSH terms:
Dysgeusia
Ear Diseases
Taste Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014