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A Randomized Controlled Trial: Efficacy of Dexamethasone Versus Methylprednisolone Intratympanic Injection for Treatment of Idiopathic Sudden Sensorineural Hearing Loss

A Randomized Controlled Trial: Efficacy of Dexamethasone Versus Methylprednisolone Intratympanic Injection for Treatment of Idiopathic Sudden Sensorineural Hearing Loss

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240930003
Enrollment
52
Registered
2024-09-30
Start date
2024-05-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Sudden Sensorineural Hearing Loss patient , within 4 weeks from onset who have not received treatment with steroids berfore or patient who have previously been treated with systemic steroids and have not response to treatment intratympanic injection,Idiopathic Sudden Sensorineural Hearing Loss , dexamethasone,Methylprednisolone

Interventions

dexamethasone 5mg/ml of Intratympanic injection ,methylprednisolone injection of Intratympanic injection
Experimental Drug,Active Comparator Drug
intratympanic injection : dexamethasone,intratympanic injection : methylprednisolone

Sponsors

Faculty of medicine Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years diagnosed with SSNHL, characterized by a loss of sensorineural hearing of at least 30 dB at three consecutive frequencies, as confirmed by Audiogram, and all symptoms occurring within 72 hours. 2. Patients with hearing loss in only one ear. 3. Patients with SSNHL within 4 weeks from onset who have not received treatment with steroids before this or patients who have previously been treated with systemic steroids and have not responded to the treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with hearing loss due to known causes such as accidents, self-immune deficiency, middle ear inflammation, unequal ear fluid, retro cochlear lesion, exposure to nerve-affecting drugs, and hearing loss from radiation. 2. Patients with fluctuating hearing loss or a history of previous hearing loss

Design outcomes

Primary

MeasureTime frame
pure tone average/speech discrimination score of post treatment at 4 week after end of the intervention audiogram (decibel),%

Secondary

MeasureTime frame
Pain score in first intratympanic injection at 4 week after end of the intervention visual analog scale

Countries

Thailand

Contacts

Public ContactNoppadon madawa

Department of otolaryngology

noppadon41598@gmail.com0805441598

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026