- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00222417
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
June 20, 2012 updated by: University Hospital of North Norway
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9038
- ENT-department, University Hospital of Tromsø
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Myringoplasty
Patients subject to myringoplasty for tympanic membrane perforations.
|
Myringoplasty is an operative procedure to close tympanic membrane perforations.
|
Otosclerosis
Patients subject to stapes surgery
|
Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative hearing threshold level
Time Frame: 1 year
|
Pure tone audiometry, speech audiometry, otoacoustic emissions
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Niels C Stenklev, MD, PhD, ENT-department, University of Tromsø, 9038 Tromsø, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
June 21, 2012
Last Update Submitted That Met QC Criteria
June 20, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFP-177-04/721170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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