Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss

NCT ID: NCT06878599

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-10-31

Brief Summary

• To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL).
• To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL.

Detailed Description

Sudden sensory neural hearing loss (SSNHL) is defined as sensorineural hearing loss of at least 30 dB over 3 consecutive frequencies within 3 days. Different treatment modalities have been used in treatment of SSNHL including systemic corticosteroids alone or in combination with vasodilators as pentoxifylline and hydroxyethylstarch (HES) or low molecular weight dextran, hyperbaric oxygen therapy & plasmapheresis.

Intratympanic (IT) dexamethasone application has shown significantly higher perilymph steroid concentrations with lower systemic concentrations, thus avoiding the side effects associated with the systemic route. It has been used with varying results for the treatment of Meniere's disease, SSNHL, low frequency hearing loss and tinnitus. After IT injection, the drug concentration in the inner ear depends on the drug being in contact with the round window membrane (RWM), absorbing it from the middle ear into the inner ear. However, large amount of the injected drugs are either absorbed by the middle ear mucosa or evacuated via the eustachian tube.

It has been postulated that combining the drug with a biodegradable material will prolong its availability in the middle ear and/or aid its diffusion across the RWM. Between these materials, Hyaluronic acid (HA) is a natural product normally present is humans' perilymph in small amounts along with many other tissues throughout the body. Several postulations have been given to HA mechanism of action in drug delivery in the middle ear either by its osmotic effect on the perilymph, modulating RWM permeability or altering blood viscosity thus increasing blood and oxygen delivery.

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyalouronic acid with dexamethasone injection

Intratympanic injection

Group Type: EXPERIMENTAL

Hyaluronic Acid (HA)

Intervention Type: COMBINATION_PRODUCT

Adding Hyaluronic acid to dexamethasone as intratympanic injection

Dexamethasone

Intervention Type: DRUG

Intratympanic injection of Dexamethasone

Dexamethasone injection

Intratympanic injection

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Intratympanic injection of Dexamethasone

Interventions

Hyaluronic Acid (HA)

Adding Hyaluronic acid to dexamethasone as intratympanic injection

Intervention Type: COMBINATION_PRODUCT

Dexamethasone

Intratympanic injection of Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult patients (aged 18 and over)

2. Patients with sudden sensory neural hearing loss (SSNHL)

Exclusion Criteria

1. Patients with middle or external ear pathology.

2. Patient with history of traumatic skull base fracture.

3. Patients with previous ear surgery.

4. Patients with other neurological symptoms or signs (Other cranial nerves affection).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mai Essam Ali AbuElmagd

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Mai AbuElmagd, Specialist

Role: CONTACT

maiessam995@gmail.com

+20882159601

Other Identifiers

Hyaluronic acid in SSNHL

Identifier Type: -

Identifier Source: org_study_id