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

NCT06830187 | Recruiting

• 1 other identifier: HacettepeU-SBA 24/365
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Otosclerosis of Middle Ear; Bone Density; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Correlation Between CT Density and Audiological Parameters

  Baseline (Preoperative assessment)

• Association Between Otosclerosis Severity and BMD/Vitamin D Levels

  Baseline (Preoperative assessment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 BMD and vitamin D data

You may not qualify if:

• 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

Sponsors & Collaborators

• İbrahim Emir Yeşil: lead

Study Sites (1)

Hacettepe University Hospitals

Ankara, 06560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Otosclerosis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gamze Atay, Assoc Prof

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

İbrahim Emir Yeşil, MD

CONTACT

+905019103056; iemiryesil@gmail.com

Gamze Atay, Assos Prof

CONTACT

+90 312 305 4224; gamze.atay@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Otorhinolaryngologist

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: January 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

TU (1)