Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Temporal Bone CT Density Measurements
研究概览
简要总结
The goal of this observational case-control study is to evaluate the relationship between temporal bone computed tomography (CT) findings, bone mineral density (BMD), and audiological parameters in adults diagnosed with otosclerosis. The main questions it aims to answer are:
Is there a correlation between temporal bone CT density values and the severity of hearing loss in otosclerosis? Do bone mineral density and serum vitamin D levels differ between otosclerosis patients and individuals without otosclerosis? Researchers will compare patients diagnosed with otosclerosis to a control group without otosclerosis to determine if CT-based density variations are associated with disease severity and systemic bone metabolism markers.
Participants who have already had a temporal bone CT scan as part of their routine clinical evaluation will undergo:
Bone mineral density (BMD) assessment via dual-energy X-ray absorptiometry (DEXA) Serum vitamin D level measurement Audiological testing, including pure tone audiometry and speech discrimination tests This study aims to improve the diagnostic and prognostic understanding of otosclerosis by integrating imaging, metabolic, and audiological data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of primary metabolic bone diseases (osteoporosis, Paget's disease)
- •Use of medications affecting bone metabolism (bisphosphonates, corticosteroids)
- •History of chronic otitis media or prior ear surgeries
- •Patients who received head and neck radiotherapy
结局指标
主要结局
Temporal Bone CT Density Measurements
时间窗: Baseline (Preoperative assessment)
Measurement of bone density at key anatomical sites including the stapes footplate, oval window, and otic capsule, using Hounsfield Units (HU) from high-resolution temporal bone CT scans.
Pure Tone Audiometry (PTA) Thresholds
时间窗: Baseline (Preoperative assessment)
Hearing thresholds will be assessed using pure tone audiometry (PTA) across standard frequencies (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz). The average PTA threshold (in dB HL) will be reported to evaluate the severity of hearing impairment.
Air-Bone Gap (ABG) Measurement
时间窗: Baseline (Preoperative assessment)
Air-bone gap (ABG) will be assessed at key frequencies (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) using pure tone audiometry. The mean ABG value (in dB HL) will be reported to evaluate the degree of conductive hearing loss.
Bone Mineral Density (BMD) Scores
时间窗: Baseline (Preoperative assessment)
Measurement of bone mineral density in lumbar spine and femoral neck using Dual-Energy X-ray Absorptiometry (DEXA) to explore systemic bone metabolism in otosclerosis patients.
Serum Vitamin D Levels
时间窗: Baseline (Preoperative assessment)
Measurement of 25-hydroxyvitamin D levels in blood samples to assess vitamin D status and its potential correlation with otosclerosis progression.
次要结局
- Correlation Between CT Density and Audiological Parameters(Baseline (Preoperative assessment))
- Association Between Otosclerosis Severity and BMD/Vitamin D Levels(Baseline (Preoperative assessment))
研究者
İbrahim Emir Yeşil
MD, Otorhinolaryngologist
Hacettepe University