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Clinical Trials/NCT06022471
NCT06022471
Not yet recruiting
Not Applicable

Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus

Assiut University0 sites32 target enrollmentSeptember 15, 2023
ConditionsOtosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otosclerosis
Sponsor
Assiut University
Enrollment
32
Primary Endpoint
decrease tinnitus
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study will be conducted on patients with otosclerosis attending Assiut University Hospital and undergo stapedectomy operation Evaluation of each patient will conducted preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to measure improvement in hearing and tinnitus

Detailed Description

Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone leading to the fixation of the stapes. * Clinical otosclerosis is more prevalent in females than in males, giving rise to the hypothesis that sex hormones may contribute to the development of disease * The age of onset is variable, although hearing loss typically begins in the third decade, with a range from first decade to the sixth decade. In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing initially in one ear before progressing to the other. Positive family history of otosclerosis has been previously reported in between 30-70% of cases. The diagnosis is usually made clinically by * History * Physical examination, * Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most frequent presentation of patients with clinical otosclerosis is bilateral hearing loss and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus. patients with tinnitus often report that their tinnitus is associated with feelings of sadness, worry, frustration, and anger. These feelings can lead to difficulties sleeping, relaxing, and concentrating and may negatively impact relationships at work and impair participation in social settings . Stapedotomy through sufficient air-bone gap closure Data collection 1. full history taking 2. tinnitus handicap questionnaire arabic version 3. Vital signs and general examination 4. Full ENT examination including ear canal and tympanic membrane examination 5. Routine audiologic testing which provide an assessment of patient hearing 6. Investigation 7. Preoperative fitness 8. Tinnitogra Tinnitogram : Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency. Tinnitus loudness match : patient threshold was determined at frequency of pitch matching, sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
August 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doaa Araby Mohamed

Resident doctor at Otolaryngology Departement, Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patient with otosclerosis undergo stapes surgery in otorhinology department in Assiut university hospital
  • All patient have tinnitus and conductive hearing loss or mixed hearing loss.

Exclusion Criteria

  • patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due to causes other than otosclerosis.

Outcomes

Primary Outcomes

decrease tinnitus

Time Frame: 3 month

Measuring tinnitus by tinnitogram By pure tone averages untile patients report that specific tone resemble their tinnitus The unit of measure for sound intensity is the decibel (dB)

Secondary Outcomes

  • Changes in pure tone averages(3 month)

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