Actively Recruiting

Age: 18Years +
All Genders
ID06830187

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

Led by İbrahim Emir Yeşil · Updated on 2025-02-20

86

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults diagnosed with otosclerosis to understand how findings from temporal bone CT scans relate to bone mineral density (BMD) and hearing ability. The study compares patients with otosclerosis to a control group without the condition to explore links between CT scan density, hearing loss severity, and levels of bone metabolism markers like vitamin D. This observational case-control study aims to improve diagnosis and prognosis for otosclerosis by combining imaging, bone health, and hearing data. Participants include adults diagnosed with otosclerosis who have had or will have surgical treatment such as stapedectomy or stapedotomy. Their high-resolution CT scans and bone metabolism markers will be analyzed. The control group consists of individuals without otosclerosis who have undergone temporal bone CT for other reasons and have no history of conductive or mixed hearing loss. Both groups will have bone mineral density and vitamin D levels assessed. During the study, participants will undergo bone mineral density tests using dual-energy X-ray absorptiometry (DEXA), serum vitamin D measurements, and audiological assessments including pure tone audiometry and speech discrimination tests. Researchers will measure CT scan density, hearing thresholds, air-bone gap, bone density, and vitamin D levels before surgery or at baseline. These assessments will help clarify relationships between imaging findings, hearing loss severity, and bone metabolism in otosclerosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Patients without otosclerosis but with temporal CT imaging for other indications
  • No history of conductive or mixed hearing loss
  • Availability of bone mineral density and vitamin D data
Not Eligible

You will not qualify if you...

  • History of primary metabolic bone diseases such as osteoporosis or Paget's disease
  • Use of medications affecting bone metabolism like bisphosphonates or corticosteroids
  • History of chronic otitis media or prior ear surgeries
  • Patients who received head and neck radiotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline (single timepoint)

Participants undergo temporal bone CT scans, audiological tests, and bone mineral density assessments to evaluate otosclerosis and related parameters.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion (approximately 1 year)

Participants' imaging and metabolic parameters are observed and compared between otosclerosis and control groups without additional interventions.

Visits as per routine clinical care; no additional study visits required

Trial Site Locations

Total: 1 location

1

Hacettepe University Hospitals

Ankara, Turkey (Türkiye), 06560

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Research Team

İ

İbrahim Emir Yeşil, MD

G

Gamze Atay, Assos Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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