Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
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|
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.
|Observational model||case control|
Post-operative hearing threshold level
time frame: 1 year
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
|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.|
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