Actively Recruiting
A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
Led by Kafrelsheikh University · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
K
Kafrelsheikh University
Lead Sponsor
A
Al-Azhar University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- Diagnosis of idiopathic sudden sensorineural hearing loss with 30 dB loss at three consecutive frequencies within 14 days of symptom onset
- Failed initial standard systemic steroid therapy or have contraindications to systemic steroids
- Willing and able to provide written informed consent
You will not qualify if you...
- Identifiable cause of hearing loss such as acoustic neuroma, Meniere's disease, or 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kafrelsheikh University
Kafr ash Shaykh, Egypt, Egypt, 33155
Actively Recruiting
Research Team
S
Saad Elzayat, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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