Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Tympanic Membrane Perforation Clinical Trial

Official title:

Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00222417
• Other study ID #: SFP-177-04/721170
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: June 20, 2012
• Start date: September 2002
• Est. completion date: December 2014

Study information

• Verified date: June 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ear Diseases
• Hearing Loss
• Hearing Loss, Conductive
• Otosclerosis
• Tympanic Membrane Perforation

Intervention

Procedure:
• myringoplasty
Myringoplasty is an operative procedure to close tympanic membrane perforations.
• Stapes surgery
Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Locations

Country	Name	City	State
Norway	ENT-department, University Hospital of Tromsø	Tromsø	Troms

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative hearing threshold level	Pure tone audiometry, speech audiometry, otoacoustic emissions	1 year	No