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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Bone Density; Otosclerosis of Middle Ear

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

• Study Contact: Name: İbrahim Emir Yeşil, MD; Phone Number: +905019103056; Email: iemiryesil@gmail.com
• Study Contact Backup: Name: Gamze Atay, Assos Prof; Phone Number: +90 312 305 4224; Email: gamze.atay@hacettepe.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Hacettepe University Hospitals
    • Contact: İbrahim Emir Yeşil, MD; Phone Number: +905019103056; Email: iemiryesil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: İbrahim Emir Yeşil
• Investigators: Study Director: Gamze Atay, Assoc Prof, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Otosclerosis; Audiology; Bone Mineral Density (BMD); Temporal Bone CT; Serum Vitamin D; Stapedectomy; Hounsfield Units
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Nutrition Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Hearing Disorders; Vitamin D Deficiency; Hearing Loss; Otosclerosis
• Other Study ID Numbers: HacettepeU-SBA 24/365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No