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

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

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

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study
Official Title:	Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Ear Disorders Hearing Disorders and Deafness Surgery

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Sensation Disorders
Otorhinolaryngologic Diseases
Nervous System Diseases
Hearing Loss, Conductive
Wounds and Injuries
Disorders of Environmental Origin
Otosclerosis

Tympanic Membrane Perforation
Ear Diseases
Signs and Symptoms
Hearing Disorders
Neurologic Manifestations
Hearing Loss

ClinicalTrials.gov processed this record on November 30, 2009