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NCT Number: NCT06878599

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

* 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.

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Key information

Conditions

Sudden Sensorineural Hearing Loss (SSNHL) Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sudden Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18 and over)
  • Patients with sudden sensory neural hearing loss (SSNHL)

Exclusion criteria

  • Patients with middle or external ear pathology.
  • Patient with history of traumatic skull base fracture.
  • Patients with previous ear surgery.
  • Patients with other neurological symptoms or signs (Other cranial nerves affection).

Treatment and study plan

Hyaluronic Acid (HA)

Combination Product

Adding Hyaluronic acid to dexamethasone as intratympanic injection

Dexamethasone

Drug

Intratympanic injection of Dexamethasone

Primary outcomes

  1. Degree of hearing improvement

    Time frame: 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.

  2. Assessing each frequency difference

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai AbuElmagd, Specialist

CONTACT

[email protected]

+20882159601

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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