Overview

This trial is active, not recruiting.

Conditions otosclerosis, tympanic membrane perforation
Treatments myringoplasty, stapes surgery
Phase phase 2/phase 3
Sponsor University Hospital of North Norway
Start date September 2002
End date December 2014
Trial size 44 participants
Trial identifier NCT00222417, SFP-177-04/721170

Summary

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients subject to myringoplasty for tympanic membrane perforations.
myringoplasty
Myringoplasty is an operative procedure to close tympanic membrane perforations.
Patients subject to stapes surgery
stapes surgery
Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Primary Outcomes

Measure
Post-operative hearing threshold level
time frame: 1 year

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Tympanic membrane perforation without chronic secretion or cholesteatoma - Suspected otosclerosis Exclusion Criteria: - Below 12 years of age - Patient not consenting to study - Perioperative findings suggesting chronic otitis or cholesteatoma - Patients not fluent in Norwegian or unable to cooperate in audiometry

Additional Information

Official title Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
Principal investigator Niels C Stenklev, MD, PhD
Description Consecutive patients 12 years or older due for myringoplasty or stapes surgery at the ENT-department, University hospital of Tromsø, in an approximate time span of one year, have been studied with the following audiometric investigations at the preoperative admission, 2, 6 and 12 months postoperatively: Transient otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, speech audiometry using spondaic recognition for air and bone-conduction. Results will be statistically analysed using the Statistical Package for the Social Sciences, with the unoperated ear (paired organ) serving as controls. The goal is to look at alternative methods for analysing the patients' preoperative hearing in order to increase the precision of clinical decision-making. The secondary goal is to elucidate the effects of middle ear surgery on the inner ear.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.