NCT06022471

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

September 5, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 25, 2023

Last Update Submit

August 31, 2023

Conditions

Otosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in pure tone averages

    3 month

Study Arms (1)

Stapes surgery

Procedure: Stapes surgery

Interventions

Stapes surgeryPROCEDURE

Stapedectomy operation

Stapes surgery

Eligibility Criteria

Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with conductive hearing loss associated with tinnitus

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otosclerosis

Interventions

Stapes Surgery

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Doaa Araby

CONTACT

01119015094doaaaraby9@gmail.com

AssiutU Hospital

CONTACT

0882354166

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at Otolaryngology Departement, Principal Investigator

Study Record Dates

First Submitted

July 25, 2023

First Posted

September 5, 2023

Study Start

September 15, 2023

Primary Completion

July 15, 2024

Study Completion

August 15, 2024

Last Updated

September 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share