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Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

NCT01584011 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2012-05-08

No results posted yet for this study

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 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.

Conditions

  • Taste Disturbance

Interventions

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.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Katarina Berling, MD · 1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584011 on ClinicalTrials.gov