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

NCT ID: NCT06830187

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-05-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

İbrahim Emir Yeşil

OTHER

Sponsor Role: lead

Responsible Party

İbrahim Emir Yeşil

MD, Otorhinolaryngologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gamze Atay, Assoc Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University Hospitals

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İbrahim Emir Yeşil, MD

Role: CONTACT

iemiryesil@gmail.com

+905019103056

Gamze Atay, Assos Prof

Role: CONTACT

gamze.atay@hacettepe.edu.tr

+90 312 305 4224

Facility Contacts

İbrahim Emir Yeşil, MD

Role: primary

iemiryesil@gmail.com

+905019103056

Other Identifiers

HacettepeU-SBA 24/365

Identifier Type: -

Identifier Source: org_study_id