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Sensorineural Hearing LossNCT06434129

Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss

An observational study of Sensorineural Hearing Loss, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Sensorineural Hearing Loss
What is being tested?
DTI
How many people
72 participants
Where
1 siteEgypt
Study dates
1 Oct 2023to 1 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Assiut university hospital patients

Who may be able to join

  • Patients with audiometrically proven SNHL

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mahmoud Aly, Master contact

00201011367958

am.8892@gmail.com

Egypt1 site, 1 recruiting
  • Faculty of Medicine of Assuit

    Asyut, 71515

    Mahmoud Aly, Master, 00201011367958, am.8892@gmail.com

    Recruiting

Other trials in Egypt

About this study

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..

Read the detailed description

Hearing is a complex process in which many parts of the ear contribute to transmit signals to the brain. The auditory system consists of both peripheral structures (external, middle, and inner ear)as well as central regions (cochlear nuclei in the medulla oblongata, superior olivary nuclei and lateral lemniscus in the pons, inferior colliculus in the midbrain, medial geniculate nuclei in the thalamus, and auditory cortex in the superior temporal Heschl gyrus). Most of auditory fibres undergo a contralateral decussation to the opposite superior olive in the region known as the trapezoid body.

The broad term "sensorineural hearing loss" (SNHL) It accounts for a substantial proportion of hearing impairment cases globally, affecting individuals of various age groups. It has been used by clinicians to refer to either malfunctioning inner ear or a retrocochlear problem affecting the canalicular vestibule-chochlear (VIII) cranial nerve and cerebellopontine angle or that involves the higher (central) auditory nuclei and neural tracts. Identifying the etiology of hearing loss is valuable to establish a treatment strategy that can help to prevent or slow down complete loss of auditory function.

The central auditory structures are involved in various processes that may occur in isolation from those involving peripheral receptors .SNHL can be a consequence of different conditions, including viral infection, tumor, ischemia, multiple sclerosis, or congenital malformations.

Despite continuous efforts to delineate the pathophysiological attributes of SNHL, the aetiology remains mostly unclear with nearly 90% of cases being idiopathic. Therefore, finding a method to accurately predict microstructural changes of the auditory circuit is extremely important.

Conventional imaging modalities, including computed tomography (CT) and magnetic resonance imaging (MRI), have offered invaluable insights into the macroscopic changes associated with SNHL, such as cochlear morphology and structural abnormalities. However, these techniques lack the sensitivity to discern subtle alterations occurring at the microstructural level, impeding a comprehensive understanding of the underlying pathophysiological processes.

DTI-MRI's ability to capture subtle changes in tissue microstructure makes it an ideal candidate for probing the intricate auditory pathways affected by SNHL. By quantifying the diffusion of water molecules along axonal pathways, DTI-MRI can uncover alterations in the integrity of auditory neural connections, which are often missed by conventional imaging methods. Furthermore, DTI-derived metrics, such as fractional anisotropy (FA), axial diffusivity (AD), radial diffusivity (RD), and mean diffusivity (MD), offer quantitative measures to characterize the white matter integrity and myelination in auditory pathways.

Being tested
DTI
Keywords
DTI, Sensorineural hearing loss
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTIDiagnostic test

    Diffusion MRI imaging

Study groups in NCT06434129
Study groupRoleWhat they receive
Casescases with SNHL
Receives: Diagnostic Test: DTI
ControlsNormal people
Receives: Diagnostic Test: DTI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of role of DTI in SNHL

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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start1 Oct 2023
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434129
Sponsor's protocol ID
1a
Status last verified
May 2024
First submitted
21 May 2024
Last updated
30 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Sensorineural Hearing Loss, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud Aly, Master (00201011367958, am.8892@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of role of DTI in SNHL (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.

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