A randomized controlled trial of treatments for ISSNHL and ALH

Phase 4

Recruiting

• Conditions: idiopathetic sudden sensorineuronal hearing loss and acute low-tone sensorineural hearing loss; ISSNHL, ALHL; D003639; ISSNHL, ALH

• Registration Number: JPRN-jRCT1031210700
• Lead Sponsor: Hyakusoku Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement rate of idiopathetic sensorineuronal hearing loss and acute low-tone sensorineural hearing loss

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse event