The Anatomic Determinants of Perforation Induced Hearing Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Eustachian Tube Function and Myringoplasty/Tympanoplasty

NCT01766856

Tympanic Membrane Perforation

TERMINATED

Evaluation of Flexible Conductive Hearing Aids

NCT07222202

Conductive Hearing Loss

RECRUITING NA

Early Detection of Noise-Induced Hearing Loss

NCT01022710

Hearing Loss, Sensorineural

WITHDRAWN

Degenerative Consequences of Congenital Deafness

NCT03866850

Congenital Deafness

TERMINATED

Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

NCT00222417

Otosclerosis Tympanic Membrane Perforation

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Conductive Hearing Loss Perforated Tympanic Membrane

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with conductive hearing loss

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No