Hydrogen therapy for sudden deafness

JRCT ID: jRCTs061190004

Registered date:07/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: idiopathic sudden sensorineural hearing loss
• Date of first enrollment: 11/06/2019
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Hydrogen group: hydrogen gas inhalation twice a day, 6days, with systemic steroid and PGE1
Placebo group: air inhalation twice a day, 6days, with systemic steroid and PGE1

Outcome(s)

• Primary Outcome: Improvements in pure-tone audiometric thresholds three months after treatment

Secondary Outcome

Improvements in pure-tone audiometric thresholds one months after treatment
ratio of "complete recovery" and "Partial recovery" three months after treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with idiopathic sudden sensorineural hearing loss
treatment started within 14 days after onset of hearing loss
can be evaluated three months after treatment
age of at least 18
Written informed consent

Exclude criteria

can not be evaluated 3 months after onset
Other etiologies
difficult to be treated with systemic steroid

Related Information

• Primary Sponsor: Hato Naohito