A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.

Recruiting now · Not applicable

Conditions studied: Sensori-Neural Deafness, Exosomes

In brief

Primary Objective To compare the efficacy of a single course of IT Exo-Dex versus conventional IT dexamethasone and exosome vehicle alone, as measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint. Secondary Objectives 1. To determine the safety and tolerability profile of IT Exo-Dex. 2. To compare the rate of hearing recovery (defined as \>10 dB improvement in PTA or recovery to within 10 dB of contralateral ear) among the three treatment groups at 1, 4, and 12 weeks. 3. To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs). 4. To characterize the pharmacokinetics and inner ear biodistribution of Exo-Dex using advanced imaging modalities (e.g., MRI with exosome-contrast agents in a sub-study cohort if applicable).

Key facts

Study ID

NCT07568184

Run by

Kafrelsheikh University

People needed

30

Starts

2026-04-03

Expected to finish

2027-08-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-65 years.
• Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset.
• Failed initial standard systemic steroid therapy (e.g., oral prednisone 1 mg/kg/day for 7-14 days) or presented with contraindications to systemic steroids.
• Willing and able to provide written informed consent.

You may not qualify if…

• Identifiable cause of hearing loss (e.g., acoustic neuroma, Meniere's disease, trauma).
• Pre-existing severe to profound hearing loss in the affected ear.
• Active middle ear infection or tympanic membrane perforation.
• History of autoimmune disease, coagulation disorders, or immunodeficiency.
• Pregnancy or lactation.
• Known hypersensitivity to dexamethasone or components of the exosome formulation.
• Participation in another interventional clinical trial within 30 days.

Where it is running

• Kafrelsheikh University — Kafr ash Shaykh, Egypt, Egypt (enrolling)

Full record on ClinicalTrials.gov

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