Intratympanic dexamethasone‑loaded exosomes versus standard ear steroid injections for sudden sensorineural hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with idiopathic sudden sensorineural hearing loss within 14 days who failed or cannot take systemic steroids are randomized to one of three single‑course intratympanic treatments: exosome‑loaded dexamethasone (Exo‑Dex), conventional intratympanic dexamethasone, or exosome vehicle alone. The primary endpoint is mean change in pure‑tone average (0.5, 1, 2, 4 kHz) from baseline to four weeks; secondary endpoints include safety, rates of hearing recovery at 1, 4, and 12 weeks, objective auditory testing (ABR and OAEs), and pharmacokinetic/biodistribution sub‑studies using advanced imaging. Exosomes are derived from human umbilical cord mesenchymal stem cells and are used as a local delivery vehicle to increase cochlear drug bioavailability while minimizing systemic exposure. The trial is conducted at Kafrelsheikh University in Egypt with regional collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18-65 years.
2. Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset.
3. 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.
4. Willing and able to provide written informed consent.

Exclusion Criteria:

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

Where it's running

• Kafrelsheikh University
  Kafr ash Shaykh, Egypt, Egypt Recruiting

Study contacts

• Study coordinator: Saad Elzayat, PhD
• Email: Samoz9@hotmail.com
• Phone: +201012788746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.