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WithdrawnNCT03271970Updated Feb 6, 2018

The Anatomic Determinants of Perforation Induced Hearing Loss

An observational study in Conductive Hearing Loss and Perforated Tympanic Membrane, sponsored by Duke University. Withdrawn. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Duke University · Observational

Why this study was withdrawn
PI no longer wishes to conduct the study. No participants were enrolled.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Conductive Hearing Loss
  • Perforated Tympanic Membrane
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with conductive hearing loss
05

What researchers measure

Primary outcomes

  1. presence of perforation

    Number of patients with perforations

    Time frame: Day 1

  2. absence of perforation

    number of patients without perforations

    Time frame: Day 1

  3. change in audiometric measurements

    looking at difference between baseline and last observation

    Time frame: Baseline, up to 16 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03271970
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Apr 2017 (estimated)
Primary completion
Jan 3, 2018
Completion
Jan 3, 2018
Last update
Feb 6, 2018

Study contacts

Dennis Frank-Ito, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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