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

ConditionSudden Sensorineural Hearing Loss (SSNHL)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged 18 and over)

Patients with sudden sensory neural hearing loss (SSNHL)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic Acid (HA)

    Combination product

    Adding Hyaluronic acid to dexamethasone as intratympanic injection

  • Dexamethasone

    Drug

    Intratympanic injection of Dexamethasone

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Hyalouronic acid with dexamethasone injectionExperimental treatment 2 interventions
Group B: Dexamethasone injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: