Sudden Sensorineural Hearing Loss (SSNHL)Phase 4NCT06878599
Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss
A Phase 4 study testing Hyaluronic Acid (HA) and Dexamethasone in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL). To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss (SSNHL)
- What is being tested?
- Hyaluronic Acid (HA) and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 and over)
- Patients with sudden sensory neural hearing loss (SSNHL)
Who cannot join
- Patients with middle or external ear pathology.
- Patient with history of traumatic skull base fracture.
- Patients with previous ear surgery.
- Patients with other neurological symptoms or signs (Other cranial nerves affection).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
- To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL).
- To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL.
Read the detailed description
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.
- Being tested
- Hyaluronic Acid (HA), Dexamethasone
- Keywords
- Hyaluronic acid, Dexamethasone, SSNHL, Sudden Sensorineural Hearing Loss
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Combination product
Adding Hyaluronic acid to dexamethasone as intratympanic injection
DexamethasoneDrug
Intratympanic injection of Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Hyalouronic acid with dexamethasone injection | Experimental | Intratympanic injection Receives: Combination Product: Hyaluronic Acid (HA); Drug: Dexamethasone |
| Dexamethasone injection | Active comparator | Intratympanic injection Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the start of injections to 4 weeks after the end of injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing Loss (SSNHL)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Essam Ali AbuElmagd, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878599
- Sponsor's protocol ID
- Hyaluronic acid in SSNHL
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT06878599
- Acronym / sponsor ID
- Hyaluronic acid in SSNHL
- Keywords
- Hyaluronic acid, Dexamethasone, SSNHL, Sudden Sensorineural Hearing Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL).
- To compare outcomes of intratympanic injection of dexamethasone and hyaluronic acid mixture to dexamethasone alone in treatment of SSNHL.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalouronic acid with dexamethasone injection | Experimental | Combination Product: Hyaluronic Acid (HA), Drug: DexamethasoneIntratympanic injection |
| Dexamethasone injection | Active comparator | Drug: DexamethasoneIntratympanic injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged 18 and over)
- Patients with sudden sensory neural hearing loss (SSNHL)
Key exclusion criteria (4 listed)
- Patients with middle or external ear pathology.
- Patient with history of traumatic skull base fracture.
- Patients with previous ear surgery.
- Patients with other neurological symptoms or signs (Other cranial nerves affection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA)Adding Hyaluronic acid to dexamethasone as intratympanic injection | Combination product | Hyalouronic acid with dexamethasone injection |
| DexamethasoneIntratympanic injection of Dexamethasone | Drug | Dexamethasone injection, Hyalouronic acid with dexamethasone injection |
Primary outcome
Degree of hearing improvement
Time frame: From the start of injections to 4 weeks after the end of injections
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.
Assessing each frequency difference
Time frame: From the start of injections to 4 weeks after the end of injections
Assessment will also measure the differences in each frequency independently between the pre and post treatment PTA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid (HA) and Dexamethasone in people with Sudden Sensorineural Hearing Loss (SSNHL), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai AbuElmagd, Specialist (+20882159601, maiessam995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of hearing improvement (time frame: From the start of injections to 4 weeks after the end of injections). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.