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Trial record 9 of 501 for:    "Ear Diseases"
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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Otosclerosis
Tympanic Membrane Perforation
 Procedure: myringoplasty
Procedure: Stapes surgery
 Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Post-operative hearing threshold level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pure tone audiometry, speech audiometry, otoacoustic emissions


Enrollment: 44
Study Start Date: September 2002
Estimated Study Completion Date: December 2014
Groups/Cohorts Assigned Interventions
Myringoplasty
Patients subject to myringoplasty for tympanic membrane perforations.
 Procedure: myringoplasty
Myringoplasty is an operative procedure to close tympanic membrane perforations.
Otosclerosis
Patients subject to stapes surgery
 Procedure: Stapes surgery
Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222417

Locations
Norway
ENT-department, University Hospital of Tromsø
Tromsø, Troms, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Principal Investigator: Niels C Stenklev, MD, PhD ENT-department, University of Tromsø, 9038 Tromsø, Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00222417     History of Changes
Other Study ID Numbers: SFP-177-04/721170
Study First Received: September 13, 2005
Last Updated: June 20, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Ear Diseases
Hearing Loss
Deafness
Hearing Loss, Conductive
Otosclerosis
Tympanic Membrane Perforation
Hearing Disorders
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013