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Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients

Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06830187
Enrollment
86
Registered
2025-02-17
Start date
2022-01-01
Completion date
2025-05-01
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Density, Otosclerosis of Middle Ear, Vitamin D Deficiency

Keywords

Otosclerosis, Temporal Bone CT, Bone Mineral Density (BMD), Serum Vitamin D, Audiology, Stapedectomy, Hounsfield Units

Brief summary

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.

Interventions

None listed

Sponsors

İbrahim Emir Yeşil
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(Otosclerosis Group): * Adults diagnosed with otosclerosis based on audiological and clinical assessment * Patients with available high-resolution CT scans and audiological data * Individuals who have undergone stapedectomy or stapedotomy surgery * Availability of bone mineral density and serum vitamin D data Inclusion Criteria (Control Group): * Patients without otosclerosis but with temporal CT imaging for other indications * No history of conductive or mixed hearing loss * Availability of BMD and vitamin D data

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pure Tone Audiometry (PTA) ThresholdsBaseline (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.
Bone Mineral Density (BMD) ScoresBaseline (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 LevelsBaseline (Preoperative assessment)Measurement of 25-hydroxyvitamin D levels in blood samples to assess vitamin D status and its potential correlation with otosclerosis progression.
Temporal Bone CT Density MeasurementsBaseline (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.
Air-Bone Gap (ABG) MeasurementBaseline (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.

Secondary

MeasureTime frameDescription
Association Between Otosclerosis Severity and BMD/Vitamin D LevelsBaseline (Preoperative assessment)Statistical analysis to determine whether systemic bone metabolism markers (BMD, serum vitamin D) correlate with otosclerosis severity, as assessed by CT and audiological tests.
Correlation Between CT Density and Audiological ParametersBaseline (Preoperative assessment)Analysis of the relationship between preoperative CT bone density values and audiometric findings to determine if CT markers predict hearing loss severity.

Countries

Turkey (Türkiye)

Contacts

Primary Contactİbrahim Emir Yeşil, MD
iemiryesil@gmail.com+905019103056
Backup ContactGamze Atay, Assos Prof
gamze.atay@hacettepe.edu.tr+90 312 305 4224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026