Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram (Otosclerosis)

Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus

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

Study Overview

• Status: Not yet recruiting
• Conditions: Otosclerosis
• Intervention / Treatment: Procedure: Stapes surgery

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

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Doaa Araby; Phone Number: 01119015094; Email: doaaaraby9@gmail.com
• Study Contact Backup: Name: AssiutU Hospital; Phone Number: 0882354166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with conductive hearing loss associated with tinnitus

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stapes surgery	Procedure: Stapes surgery; Stapedectomy operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pure tone averages	Pure tone averages calculated from pure tone audiometry will be summarized using the mean	3 month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus; Otosclerosis
• Other Study ID Numbers: Outcome of ss in ot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No