Clinical trial NCT06830187: Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Official title: Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Temporal Bone CT Density Measurements
timeFrame: Baseline (Preoperative assessment)
measure: Pure Tone Audiometry (PTA) Thresholds
timeFrame: Baseline (Preoperative assessment)
measure: Air-Bone Gap (ABG) Measurement
timeFrame: Baseline (Preoperative assessment)
measure: Bone Mineral Density (BMD) Scores
timeFrame: Baseline (Preoperative assessment)
measure: Serum Vitamin D Levels
timeFrame: Baseline (Preoperative assessment)
Secondary outcomes:
measure: Correlation Between CT Density and Audiological Parameters
timeFrame: Baseline (Preoperative assessment)
measure: Association Between Otosclerosis Severity and BMD/Vitamin D Levels
timeFrame: Baseline (Preoperative assessment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospitals
Study officials:
affiliation: Hacettepe University
name: Gamze Atay, Assoc Prof
role: STUDY_DIRECTOR
References: