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Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00222417
Enrollment
44
Registered
2005-09-22
Start date
2002-09-30
Completion date
2014-12-31
Last updated
2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis, Tympanic Membrane Perforation

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.

Interventions

PROCEDUREmyringoplasty

Myringoplasty is an operative procedure to close tympanic membrane perforations.

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

Sponsors

University Hospital of North Norway
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative hearing threshold level1 yearPure tone audiometry, speech audiometry, otoacoustic emissions

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026