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Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00222417
First received: September 13, 2005
Last updated: June 20, 2012
Last verified: June 2012

September 13, 2005
June 20, 2012
September 2002
Not Provided
Post-operative hearing threshold level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Pure tone audiometry, speech audiometry, otoacoustic emissions
Not Provided
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
December 2014
Not Provided

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
No
University Hospital of North Norway
University Hospital of North Norway
Not Provided
Principal Investigator: Niels C Stenklev, MD, PhD ENT-department, University of Tromsø, 9038 Tromsø, Norway
University Hospital of North Norway
June 2012

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