A Phase 4 interventional study of Hyaluronic Acid (HA) and Dexamethasone in Sudden Sensorineural Hearing Loss (SSNHL), sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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.
66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 49 interventional studies indexed under Hearing Loss, Sudden.
Browse Hearing Loss, Sudden studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Intratympanic injection
Combination Product: Hyaluronic Acid (HA) · Drug: Dexamethasone
Intratympanic injection
Drug: Dexamethasone
Adding Hyaluronic acid to dexamethasone as intratympanic injection
Intratympanic injection of Dexamethasone
Degree of hearing improvement
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.
Time frame: From the start of injections to 4 weeks after the end of injections
Assessing each frequency difference
Assessment will also measure the differences in each frequency independently between the pre and post treatment PTA.
Time frame: From the start of injections to 4 weeks after the end of injections
Start is estimated for May 2025; primary completion for Oct 2027, 29 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid