The Anatomic Determinants of Perforation Induced Hearing Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- presence of perforation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
presence of perforation
Time Frame: Day 1
Number of patients with perforations
absence of perforation
Time Frame: Day 1
number of patients without perforations
change in audiometric measurements
Time Frame: Baseline, up to 16 weeks
looking at difference between baseline and last observation
Secondary Outcomes
No secondary outcomes reported