A randomized controlled trial of treatments for ISSNHL and ALHL

JRCT ID: jRCT1031210700

Registered date:26/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: idiopathetic sudden sensorineuronal hearing loss and acute low-tone sensorineural hearing loss
• Date of first enrollment: 26/03/2022
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 prednisolone is 150 or 200mg. Tapering off in 9 days.

Outcome(s)

• Primary Outcome: Improvement rate of idiopathetic sensorineuronal hearing loss and acute low-tone sensorineural hearing loss
• Secondary Outcome: Incidence of adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hyakusoku Hiroshi