Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss

NCT06878599 | Not Yet Recruiting Phase 4

• 1 other identifier: Hyaluronic acid in SSNHL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Keywords

Hyaluronic acid; Dexamethasone; SSNHL; Sudden Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the start of injections to 4 weeks after the end of injections

Study Arms (2)

Hyalouronic acid with dexamethasone injection

EXPERIMENTAL

Intratympanic injection

Combination Product: Hyaluronic Acid (HA); Drug: Dexamethasone

Dexamethasone injection

ACTIVE COMPARATOR

Intratympanic injection

Drug: Dexamethasone

Interventions

Hyaluronic Acid (HA) COMBINATION_PRODUCT

Adding Hyaluronic acid to dexamethasone as intratympanic injection

Hyalouronic acid with dexamethasone injection

Dexamethasone DRUG

Intratympanic injection of Dexamethasone

Dexamethasone injection; Hyalouronic acid with dexamethasone injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18 and over)
• Patients with sudden sensory neural hearing loss (SSNHL)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Hyaluronic Acid; Dexamethasone

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Mai AbuElmagd, Specialist

CONTACT

+20882159601; maiessam995@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

EG (1)