OtosclerosisNCT00222417
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
An observational study of Otosclerosis and Tympanic Membrane Perforation, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Otosclerosis, Tympanic Membrane Perforation
- What is being tested?
- myringoplasty and Stapes surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2002to 3 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.
Who may be able to join
- Tympanic membrane perforation without chronic secretion or cholesteatoma
- Suspected otosclerosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Otosclerosis, Tympanic Membrane Perforation
- Being tested
- myringoplasty, Stapes surgery
- Medical subject headings
- Otosclerosis, Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myringoplastyProcedure or surgery
Myringoplasty is an operative procedure to close tympanic membrane perforations.
Stapes surgeryProcedure or surgery
Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Myringoplasty | Patients subject to myringoplasty for tympanic membrane perforations. Receives: Procedure: myringoplasty | |
| Otosclerosis | Patients subject to stapes surgery Receives: Procedure: Stapes surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hearing threshold level
Pure tone audiometry, speech audiometry, otoacoustic emissions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2002
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Why it stopped: Study not startet. PI not working at the Universityhospital of North Norway
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels C Stenklev, MD, PhD, Principal investigator, ENT-department, University of Tromsø, 9038 Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222417
- Sponsor's protocol ID
- SFP-177-04/721170
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
- ClinicalTrials.gov ID
- NCT00222417
- Acronym / sponsor ID
- SFP-177-04/721170
- Conditions
- Otosclerosis, Tympanic Membrane Perforation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not startet. PI not working at the Universityhospital of North Norway
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myringoplasty | – | Procedure: myringoplastyPatients subject to myringoplasty for tympanic membrane perforations. |
| Otosclerosis | – | Procedure: Stapes surgeryPatients subject to stapes surgery |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.
Key inclusion criteria (2 listed)
- Tympanic membrane perforation without chronic secretion or cholesteatoma
- Suspected otosclerosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myringoplastyMyringoplasty is an operative procedure to close tympanic membrane perforations. | Procedure or surgery | Myringoplasty |
| Stapes surgeryOperative procedure aimed to replace non-functioning stapes with a synthetic prosthesis | Procedure or surgery | Otosclerosis |
Primary outcome
Post-operative hearing threshold level
Time frame: 1 year
Pure tone audiometry, speech audiometry, otoacoustic emissions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels C Stenklev, MD, PhD principal investigator
ENT-department, University of Tromsø, 9038 Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis and Tympanic Membrane Perforation, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative hearing threshold level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.