The Anatomic Determinants of Perforation Induced Hearing Loss

Learn more about:
Related Clinical Trial
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population Evaluation of Sound Processor for a Transcutaneous System Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) Clinical Survey of Different Abutment Topologies Clinical Survey of Oticon Medical Healing Cap Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation Quality of Life With Bone Conduction Hearing Device Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System Hearing for Learning Initiative – a Health Facilitator Model for Otitis Media Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini SoundBite Hearing System Long Term Multi Site Patient Use Study SoundBite Hearing System 24 Month Multi Site Patient Use Study Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study Ambispective Clinical Evaluation of Sophono™ The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss Osia CPT Code Study The Anatomic Determinants of Perforation Induced Hearing Loss

Brief Title

The Anatomic Determinants of Perforation Induced Hearing Loss

Official Title

The Anatomic Determinants of Perforation Induced Hearing Loss

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 Type

Observational


Primary Outcome

presence of perforation


Condition

Conductive Hearing Loss


Study Arms / Comparison Groups

 Patients with conductive hearing loss
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

0

Start Date

April 2017

Completion Date

January 3, 2018

Primary Completion Date

January 3, 2018

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

Dennis Frank-Ito, PhD, , 



Administrative Informations


NCT ID

NCT03271970

Organization ID

Pro00073436


Responsible Party

Sponsor

Study Sponsor

Duke University


Study Sponsor

Dennis Frank-Ito, PhD, Principal Investigator, Duke University


Verification Date

January 2018