The Anatomic Determinants of Perforation Induced Hearing Loss

NCT03271970 | Withdrawn

• 1 other identifier: Pro00073436
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Conductive Hearing Loss; Perforated Tympanic Membrane

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with conductive hearing loss

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Hearing Loss, Conductive; Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Dennis Frank-Ito, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: September 5, 2017
• Study Start: April 1, 2017
• Primary Completion: January 3, 2018
• Study Completion: January 3, 2018
• Last Updated: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share