Cochlear implantation for unilateral hearing loss

Phase 3

Recruiting

• Conditions: nilateral severe to profound sensorineural hearing loss

• Registration Number: JPRN-jRCTs032200430
• Lead Sponsor: Iwasaki Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

General 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.

Exclusion Criteria

The 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For 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 Outcome Measures

Name	Time	Method
As the secondary endpoints, the sound localization test and audiometric test using free field audiometry are performed before operation and 12 months after CI fitting.<br>Marked recovery is defined as the average improvement of the intervention group is significantly better than that of the non-treatment historical group.