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Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
This study is ongoing, but not recruiting participants.
Study NCT00222417   Information provided by University Hospital of North Norway
First Received: September 13, 2005   Last Updated: October 16, 2006   History of Changes

September 13, 2005
October 16, 2006
September 2002
 
 
 
Complete list of historical versions of study NCT00222417 on ClinicalTrials.gov Archive Site
 
 
 
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

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.

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.

Phase II, Phase III
Observational
Longitudinal, Defined Population, Prospective Study
  • Otosclerosis
  • Tympanic Membrane Perforation
Procedure: Observational study: hearing effect of middle ear surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
44
December 2004
 

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00222417
 
SFP-177-04/721170
University Hospital of North Norway
 
Principal Investigator: Niels C Stenklev, MD, PhD ENT-department, University of Tromsø, 9038 Tromsø, Norway
University Hospital of North Norway
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP