The Anatomic Determinants of Perforation Induced Hearing Loss

Conductive Hearing Loss Clinical Trial

Official title:

The Anatomic Determinants of Perforation Induced Hearing Loss

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03271970
• Other study ID #: Pro00073436
• Status: Withdrawn
• Phase: N/A
• First received: August 17, 2017
• Last updated: February 5, 2018
• Start date: April 2017
• Est. completion date: January 3, 2018

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 3, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Perforated Tympanic Membrane
• Tympanic Membrane Perforation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of perforation	Number of patients with perforations	Day 1
Primary	absence of perforation	number of patients without perforations	Day 1
Primary	change in audiometric measurements	looking at difference between baseline and last observation	Baseline, up to 16 weeks