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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200430

Registered date:01/04/2021

Cochlear implantation for unilateral hearing loss

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnilateral severe to profound sensorineural hearing loss
Date of first enrollment01/04/2021
Target sample size38
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The cochlear implantation is performed under general anesthesia. Same as standard cochlea implant surgeries for bilateral healing loss, an antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy and insert cochlear implant electrode to cochlea and fix implanted electrode and signal receiver. The implant system can be activated, after the swelling of the skin flap above the implant has reduced.

Outcome(s)

Primary OutcomeFor the primary endpoint, speech perception test by using 67S Japanese monosyllable word table under the SoNnh, SN+0dB noise condition (Japan Audiological Society 1967, 1957) is performed before operation and 12 months after CI fitting.Marked recovery is defined as the average improvement of CI intervention group is significantly better than that of non-treated historical control group (N=17, average improvement: 10.9%, standard deviation: 24.4) by t-test or Wilcoxon signed-rank test.
Secondary OutcomeAs the secondary endpoints, the sound localization test and audiometric test using free field audiometry are performed before operation and 12 months after CI fitting. Marked recovery is defined as the average improvement of the intervention group is significantly better than that of the non-treatment historical group.

Key inclusion & exclusion criteria

Age minimum>= 6age old
Age maximumNot applicable
GenderBoth
Include criteriaGeneral criteria (1) Patient agreed to participate in the study and signed to the informed consent document. (if patient is a monor, patiens or legal guardians sign to the informed consent document.) (2) Age of 6 years or older when agreed. Audiological criteria (1) The patient withbpost-lingual onset unilateral severe to profound sensorineural hearing loss. (2) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of affected side was 70dBHL or more, or 30% or less speech perception score in affected ear with hearing aid. (3) The onset of hearing loss was 6 months or more and expect the insufficient improvement of hearing ability by conventional treatment. (4) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of contralateral side was 40dBHL oe less.
Exclude criteriaThe patients with below situations were exclude from this study. (1) Hearing recovery was observed in past 6 month greater than 15dB. (2) Cochear ossification in patients with hearing loss (meningitis, otosclerosis). (3) Severe malformation and cochlear obstraction. (4) Severe outer ear malformation and does not wear audioprosessor. (5) High risk for general anesthesia. (6) Active middle eat infection. (7) Clearly evidenced retro-labryinthine hearing loss adult. (8) Severe mental retardation adult.

Related Information

Contact

Public contact
Name Satoshi Iwasaki
Address 1-4-3 Mita, Minatoku, Tokyo Tokyo Japan 108-8329
Telephone +81-3-3451-8121
E-mail iwasakis@iuhw.ac.jp
Affiliation International University of Health and Welfare Mita Hospital
Scientific contact
Name Satoshi Iwasaki
Address 1-4-3 Mita, Minatoku, Tokyo Tokyo Japan 108-8329
Telephone +81-3-3451-8121
E-mail iwasakis@iuhw.ac.jp
Affiliation International University of Health and Welfare Mita Hospital