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Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

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ClinicalTrials.gov Identifier: NCT00222417
Recruitment Status : Unknown
Verified June 2012 by University Hospital of North Norway.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):

September 13, 2005
September 22, 2005
June 21, 2012
September 2002
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Post-operative hearing threshold level [ Time Frame: 1 year ]
Pure tone audiometry, speech audiometry, otoacoustic emissions
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Complete list of historical versions of study NCT00222417 on ClinicalTrials.gov Archive Site
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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.
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.
  • Otosclerosis
  • Tympanic Membrane Perforation
  • Procedure: myringoplasty
    Myringoplasty is an operative procedure to close tympanic membrane perforations.
  • Procedure: Stapes surgery
    Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis
  • Myringoplasty
    Patients subject to myringoplasty for tympanic membrane perforations.
    Intervention: Procedure: myringoplasty
  • Otosclerosis
    Patients subject to stapes surgery
    Intervention: Procedure: Stapes surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2014
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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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University Hospital of North Norway
University Hospital of North Norway
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Principal Investigator: Niels C Stenklev, MD, PhD ENT-department, University of Tromsø, 9038 Tromsø, Norway
University Hospital of North Norway
June 2012