Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Key facts
- Who runs it
- İbrahim Emir Yeşil
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 86 people, planned
- Started
- 1 Jan 2022
- Planned end
- 1 May 2025
- Type of study
- Observational, 2 groups
- Record updated
- 20 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Use of medications affecting bone metabolism (bisphosphonates, corticosteroids)
- History of chronic otitis media or prior ear surgeries
- Patients who received head and neck radiotherapy
- History of primary metabolic bone diseases (osteoporosis, Paget's disease)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 2 groups in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss
- Record updated
- 20 February 2025