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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06022471
Other study ID # Outcome of ss in ot
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2023
Est. completion date August 15, 2024

Study information

Verified date July 2023
Source Assiut University
Contact Doaa Araby
Phone 01119015094
Email doaaaraby9@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date August 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Stapes surgery
Stapedectomy operation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary decrease tinnitus 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) 3 month
Secondary Changes in pure tone averages Pure tone averages calculated from pure tone audiometry will be summarized using the mean 3 month
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