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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022471
Collaborator
(none)
32
11

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Aug 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Stapes surgery

Procedure: Stapes surgery
Stapedectomy operation

Outcome Measures

Primary Outcome Measures

  1. decrease tinnitus [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 Outcome Measures

  1. Changes in pure tone averages [3 month]

    Pure tone averages calculated from pure tone audiometry will be summarized using the mean

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Doaa Araby Mohamed, Resident doctor at Otolaryngology Departement, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06022471
Other Study ID Numbers:
  • Outcome of ss in ot
First Posted:
Sep 5, 2023
Last Update Posted:
Sep 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2023