Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

NCT01584011 | Unknown DMC

• 2 other identifiers: CTN1CTN12
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Taste; Chorda tympani nerve

Outcome Measures

Primary Outcomes (1)

• 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.

  One year postoperative

Secondary Outcomes (2)

• Quality of life

  one year

• Histopathological changes

  At the time of surgery

Study Arms (1)

Middle ear disease

Other: taste measurement; Other: Symptom questionnaire; Behavioral: Quality of life questionnaire; Other: Nerve sample

Interventions

taste measurement OTHER

Taste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery

Middle ear disease

Symptom questionnaire OTHER

Answering a symptom questionnaire before and after surgery until one year after surgery

Middle ear disease

Quality of life questionnaire BEHAVIORAL

Answering a quality of life questionnaire before and one year after surgery

Middle ear disease

Nerve sample OTHER

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.

Middle ear disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Not primary surgery
• Not able to participate

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Vastmanlands sjukhus ENT department

Västerås, 72189, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of nerve tissue

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarina Berling, MD

  1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Berling, MD

CONTACT

+46735303045; katarina.berling@spray.se

Magnus vonUnge, PhD, Professor

CONTACT

+46733849463; magnusvu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Last Updated: May 8, 2012

Record last verified: 2012-04

Locations

SE (1)