A Phase II Randomized Trial of Dexamethasone-Loaded Exosomes Versus Standard Therapy Delivered Intratympanically for Acute Sensorineural Hearing Loss

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new drug delivery method using dexamethasone-loaded exosomes compared to standard intratympanic dexamethasone and exosome vehicle alone in adults with sudden sensorineural hearing loss (SSNHL). This condition involves rapid hearing loss of 30 decibels or more over three frequencies within 72 hours, with causes often unknown but possibly related to infections, immune responses, or blood flow issues in the ear. The study aims to improve drug delivery to the inner ear and reduce systemic side effects. The trial includes three treatment groups: one receiving standard dexamethasone injections into the middle ear, another receiving exosomes alone, and the third receiving exosomes loaded with dexamethasone. These treatments are given as a single course through intratympanic administration. The researchers will assess how well the treatments improve hearing and how the drugs distribute within the ear, using advanced imaging and hearing tests over several weeks. Participants will undergo hearing assessments including pure-tone average tests, auditory brainstem response, and otoacoustic emissions at baseline and follow-up visits at 1, 4, and 12 weeks after treatment. Safety and tolerability will be closely monitored. The main measurement is the change in hearing levels four weeks after treatment. The study will last up to six months for each participant, with detailed evaluations to understand the drug's effects and safety profile throughout this period.

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