NCT06434129

Brief Summary

DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients who are scheduled to undergo cochlear implantation and whose standard assessments have been unable to determine the functional integrity of the auditory pathway. These techniques aid in decision-making processes regarding potential outcomes, determining the optimal side for implantation, providing counseling regarding the possibility of limited benefits from surgery, and considering alternative forms of rehabilitation. The investigators including patients with varying degrees of hearing loss, as well as patients with normal radiological findings who are scheduled for cochlear implantation. The ultimate goal is to create a comprehensive map across the entire hearing spectrum and validate the findings of this study..

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 21, 2024

Last Update Submit

May 23, 2024

Conditions

Sensorineural Hearing Loss

Keywords

DTISensorineural hearing loss

Outcome Measures

Primary Outcomes (1)

  • Assessment of role of DTI in SNHL

    Assess the integrity of auditory pathway via measuring DTI metrics ( Fractional anisotropy and mean diffusivity)

    one year

Study Arms (2)

Cases

cases with SNHL

Diagnostic Test: DTI

Controls

Normal people

Diagnostic Test: DTI

Interventions

DTIDIAGNOSTIC_TEST

Diffusion MRI imaging

CasesControls

Eligibility Criteria

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

Assiut university hospital patients

You may qualify if:

  • Patients with audiometrically proven SNHL

You may not qualify if:

  • Neurologically or psychiatric conditions affecting patient stability during MRI examination.
  • Cochlear implants.
  • Contraindications for MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Assuit

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud Aly, Master

CONTACT

00201011367958am.8892@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 30, 2024

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

EG(1)