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A randomized controlled trial of treatments for ISSNHL and ALHL

A randomized controlled trial comparing low or high doses of systemic steroids for idiopathetic sudden sensorineuronal hearing loss and acute low-tone sensorineural hearing loss

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031210700
Enrollment
160
Registered
2022-03-26
Start date
2022-03-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

idiopathetic sudden sensorineuronal hearing loss and acute low-tone sensorineural hearing loss ISSNHL, ALHL

Interventions

Randomized controlled trial of steroid dose High-dose steroid administration group. start dose of prednisolone is 30mg. Tapering off in 9 days. Low-dose steroid administration group. start dose of pr
Randomized Controlled Trial

Sponsors

Hyakusoku Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Within 2 weeks of the first onset of idiopathic sudden sensorineural hearing loss and acute low-tone sensorineural hearing loss 2. Not treated with steroids 3. Obtained written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are contraindications or relative contraindications to administration of test drug, prednisolone and dexamethasone. 2. A case of ipsilateral sensorineural hearing loss in the past. (presbycusis is not included.) 3. If there is a disease in the middle ear or outer ear at the time of contract the disease, and pure tone audiometry shows that the average (250, 500, 1000, 2000 and 4000 Hz) of air-bone gap differences is 10 dB or more. 4. Among cases in which the contralateral ear has suffered from ear disease in the past and presents with hearing loss, there is no pure tone audiometry (within the past 5 years) before the contract the disease. 5. A case that develops with sudden hearing loss and is found to be another disease by subsequent scrutiny and progress.

Design outcomes

Primary

MeasureTime frame
Improvement rate of idiopathetic sensorineuronal hearing loss and acute low-tone sensorineural hearing loss

Secondary

MeasureTime frame
Incidence of adverse event

Contacts

Public ContactHiroshi Hyakusoku

Yokosuka Kyosai Hospital

hhyaku@yokohama-cu.ac.jp+81-46-822-2710

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026