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

Last updated: March 13, 2025
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

Dexamethasone

Hyaluronic Acid (HA)

Clinical Study ID

NCT06878599
Hyaluronic acid in SSNHL
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients (aged 18 and over)

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

Exclusion

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).

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Dexamethasone
Phase: 4
Study Start date:
May 01, 2025
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Assiut University Hospital

    Assiut, Asyut 71111
    Egypt

    Site Not Available

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