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Taste Disturbance | Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

Taste Disturbance research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Taste Disturbance

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:taste measurementTaste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery

Other:Symptom questionnaireAnswering a symptom questionnaire before and after surgery until one year after surgery

Behavioral:Quality of life questionnaireAnswering a quality of life questionnaire before and one year after surgery

Other: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Middle ear disease

Study Status

Unknown status

Start Date: January 2010

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: Taste disturbance

Secondary Outcome: Quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Katarina Berling, MD

Lead Sponsor: Uppsala University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01584011

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