The Anatomic Determinants of Perforation Induced Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- presence of perforation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Temporal CT scan with inadequate resolution as per determination of study staff
- •Unable to provide written informed consent
- •Unable to read and understand English
结局指标
主要结局
presence of perforation
时间窗: Day 1
Number of patients with perforations
absence of perforation
时间窗: Day 1
number of patients without perforations
change in audiometric measurements
时间窗: Baseline, up to 16 weeks
looking at difference between baseline and last observation
次要结局
未报告次要终点