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
