Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease - Full Text View

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: Observational study: hearing effect of middle ear surgery	Phase II Phase III

Genetics Home Reference related topics:

nonsyndromic deafness

MedlinePlus related topics:

Ear Disorders Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study

Official Title:	Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

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

Estimated Enrollment:	44
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2004

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

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, Troms
	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

Study ID Numbers:	SFP-177-04/721170
First Received:	September 13, 2005
Last Updated:	October 16, 2006
ClinicalTrials.gov Identifier:	NCT00222417
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:

Sensation Disorders

Otorhinolaryngologic Diseases

Conductive hearing loss

Hearing Loss, Conductive

Wounds and Injuries

Disorders of Environmental Origin

Otosclerosis

Tympanic Membrane Perforation

Ear Diseases

Signs and Symptoms

Deafness

Hearing Disorders

Neurologic Manifestations

Hearing Loss

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University Hospital of North Norway
Information provided by:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00222417