---
title: Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
nct_id: NCT00222417
overall_status: UNKNOWN
sponsor: University Hospital of North Norway
study_type: OBSERVATIONAL
primary_condition: Otosclerosis
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00222417.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00222417"
ct_last_update_post_date: 2012-06-21
last_seen_at: "2026-05-12T06:50:06.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

**NCT ID:** [NCT00222417](https://clinicaltrials.gov/study/NCT00222417)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** University Hospital of North Norway
- **Conditions:** Otosclerosis, Tympanic Membrane Perforation
- **Start Date:** 2002-09
- **Completion Date:** 2014-12
- **CT.gov Last Update:** 2012-06-21

## 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.

## Eligibility

- **Minimum age:** 12 Years
- **Sex:** ALL
- **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
```

## Arms

- **Myringoplasty** — Patients subject to myringoplasty for tympanic membrane perforations.
- **Otosclerosis** — Patients subject to stapes surgery

## Interventions

- **myringoplasty** (PROCEDURE) — Myringoplasty is an operative procedure to close tympanic membrane perforations.
- **Stapes surgery** (PROCEDURE) — Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

## Primary Outcomes

- **Post-operative hearing threshold level** _(time frame: 1 year)_ — Pure tone audiometry, speech audiometry, otoacoustic emissions

## Locations (1)

- ENT-department, University Hospital of Tromsø, Tromsø, Troms, Norway

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.ent-department, university hospital of tromsø|tromsø|troms|norway` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00222417.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00222417*  
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