NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061190004

Registered date:07/06/2019

Hydrogen therapy for sudden deafness

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedidiopathic sudden sensorineural hearing loss
Date of first enrollment11/06/2019
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeImprovements in pure-tone audiometric thresholds three months after treatment
Secondary OutcomeImprovements 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 maximumNot applicable
GenderBoth
Include criteriaPatients 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 criteriacan not be evaluated 3 months after onset Other etiologies difficult to be treated with systemic steroid

Related Information

Contact

Public contact
Name Masahiro Okada
Address Shitsukawa, Toon, Ehime, Japan Ehime Japan 791-0295
Telephone +81-89-960-5366
E-mail okadama@m.ehime-u.ac.jp
Affiliation Ehime University Hospital
Scientific contact
Name Naohito Hato
Address Shitsukawa, Toon, Ehime, Japan Ehime Japan 791-0295
Telephone +81-89-960-5366
E-mail nhato@m.ehime-u.ac.jp
Affiliation Ehime University Hospital