The Anatomic Determinants of Perforation Induced Hearing Loss

Withdrawn

• Conditions: Conductive Hearing Loss; Perforated Tympanic Membrane

• Registration Number: NCT03271970
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to identify factors that may contribute to conductive hearing loss. Conductive hearing loss is a type that is due to a problem with the outer or middle ear. Because of this, sound does not travel through the ear normally. Perforated tympanic membranes of study patients will be photographed during the patient's routine visit using a digital otoscope. These pictures will be used to analyze perforation size as an absolute value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of temporal bone (reports and images) collected as standard of care will be evaluated. Images of CT scans will be imported into a medical imaging software for creation of anatomically realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be recorded, and data points will be correlated with perforation size and location to audiogram results.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Status Verified: 2018-01
• Primary Completion: 2018-01-03
• Study Completion: 2018-01-03
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Between 18 and 89 years of age
• Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane perforation
• Treated for the above condition by a Duke physician
• Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry at a Duke-based facility (both tests performed within four weeks of each other), as part of standard pre-operative workup

Read More

Exclusion Criteria

• Temporal CT scan with inadequate resolution as per determination of study staff
• Unable to provide written informed consent
• Unable to read and understand English

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presence of perforation	Day 1	Number of patients with perforations
absence of perforation	Day 1	number of patients without perforations
change in audiometric measurements	Baseline, up to 16 weeks	looking at difference between baseline and last observation