Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

NCT ID: NCT00222417

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Otosclerosis; Tympanic Membrane Perforation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Myringoplasty

Patients subject to myringoplasty for tympanic membrane perforations.

myringoplasty

Intervention Type: PROCEDURE

Myringoplasty is an operative procedure to close tympanic membrane perforations.

Otosclerosis

Patients subject to stapes surgery

Stapes surgery

Intervention Type: PROCEDURE

Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Interventions

myringoplasty

Myringoplasty is an operative procedure to close tympanic membrane perforations.

Intervention Type: PROCEDURE

Stapes surgery

Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels C Stenklev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT-department, University of Tromsø, 9038 Tromsø, Norway

Locations

ENT-department, University Hospital of Tromsø

Tromsø, Troms, Norway

Countries

Norway

Other Identifiers

SFP-177-04/721170

Identifier Type: -

Identifier Source: org_study_id