The Anatomic Determinants of Perforation Induced Hearing Loss

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.

Study Overview

• Status: Withdrawn
• Conditions: Conductive Hearing Loss; Perforated Tympanic Membrane

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with conductive hearing loss due to tympanic membrane perforation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with conductive hearing loss

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Actual): January 3, 2018
• Study Completion (Actual): January 3, 2018

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Tympanic Membrane Perforation
• Other Study ID Numbers: Pro00073436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No