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

Phase 4

Not yet recruiting

• Conditions: Sudden Sensorineural Hearing Loss (SSNHL)
• Interventions: Combination Product: Hyaluronic Acid (HA); Drug: Dexamethasone

• Registration Number: NCT06878599
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-05-01
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyalouronic acid with dexamethasone injection	Hyaluronic Acid (HA)	Intratympanic injection
Hyalouronic acid with dexamethasone injection	Dexamethasone	Intratympanic injection
Dexamethasone injection	Dexamethasone	Intratympanic injection

Primary Outcome Measures

Name	Time	Method
Degree of hearing improvement	From the start of injections to 4 weeks after the end of injections	Using Pure Tone Audiometry (PTA), patients will be assessed once prior to the start of intratympanic injections, at its end and 4 weeks after. A 30 dB improvement in bone conduction threshold (BCT) in PTA is considered a significant improvement, while improvements of 10-30 dB and \>10 dB are considered as partial recovery and non-recovery respectively.
Assessing each frequency difference	From the start of injections to 4 weeks after the end of injections	Assessment will also measure the differences in each frequency independently between the pre and post treatment PTA.

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Asyut, Egypt