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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otosclerosis Group | Participants diagnosed with otosclerosis based on clinical and audiological criteria. These individuals have undergone or are planned for stapedectomy or stapedotomy surgery. High-resolution CT scans and bone metabolism markers will be analyzed to assess correlations with disease severity. | ||
| Control Group | Individuals without otosclerosis who have undergone temporal bone CT imaging for unrelated reasons. They have no history of conductive or mixed hearing loss. Their imaging and metabolic parameters will be compared with those of the otosclerosis patients to identify significant differences. |
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| Measure | Description | Time Frame |
|---|---|---|
| Temporal Bone CT Density Measurements | 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. | Baseline (Preoperative assessment) |
| Pure Tone Audiometry (PTA) Thresholds | 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. | Baseline (Preoperative assessment) |
| Air-Bone Gap (ABG) Measurement | 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. | Baseline (Preoperative assessment) |
| Bone Mineral Density (BMD) Scores | 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. | Baseline (Preoperative assessment) |
| Serum Vitamin D Levels | Measurement of 25-hydroxyvitamin D levels in blood samples to assess vitamin D status and its potential correlation with otosclerosis progression. | Baseline (Preoperative assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between CT Density and Audiological Parameters | Analysis of the relationship between preoperative CT bone density values and audiometric findings to determine if CT markers predict hearing loss severity. | Baseline (Preoperative assessment) |
| Association Between Otosclerosis Severity and BMD/Vitamin D Levels |
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Inclusion Criteria (Otosclerosis Group):
Inclusion Criteria (Control Group):
Exclusion Criteria:
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The study population consists of adult patients evaluated at the Otorhinolaryngology Department of Hacettepe University for hearing-related concerns. Participants will be selected from individuals who have undergone audiological testing and temporal bone computed tomography (CT) imaging as part of their clinical assessment.
The study includes two groups:
Otosclerosis Patients (Study Group): Adults diagnosed with otosclerosis based on clinical, audiological, and radiological criteria. These patients have undergone or are scheduled for stapedectomy or stapedotomy surgery.
Non-Otosclerosis Patients (Control Group): Individuals who have no clinical or audiological signs of otosclerosis but have undergone temporal bone CT for unrelated reasons, such as investigation of other otologic symptoms (e.g., vertigo, tinnitus, or trauma assessment).
Participants will primarily be recruited from tertiary care settings within the hospital, ensuring access to specialized diagnostic and surgical inter
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İbrahim Emir Yeşil, MD | Contact | +905019103056 | iemiryesil@gmail.com | |
| Gamze Atay, Assos Prof | Contact | +90 312 305 4224 | gamze.atay@hacettepe.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Gamze Atay, Assoc Prof | Hacettepe University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Hospitals | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D010040 | Otosclerosis |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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Statistical analysis to determine whether systemic bone metabolism markers (BMD, serum vitamin D) correlate with otosclerosis severity, as assessed by CT and audiological tests. |
| Baseline (Preoperative assessment) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |