UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052993 |
|---|---|
| Receipt number | R000060459 |
| Scientific Title | Evaluation of listening performance in quiet and noisy conditions in unilateral cochlear implant users |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/10/18 13:55:38 |
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Basic information
Public title
Evaluation of listening performance in quiet and noisy conditions in unilateral cochlear implant users
Acronym
Evaluation of listening performance in unilateral cochlear implant users
Scientific Title
Evaluation of listening performance in quiet and noisy conditions in unilateral cochlear implant users
Scientific Title:Acronym
Evaluation of listening performance in unilateral cochlear implant users
Region
| Japan |
Condition
Condition
bilateral sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the extent to which speech perception from the non-wearing side (or the non-wearing ear in bilateral wearers) is affected by noise from the wearing side in unilateral and bilateral cochlear implant wearers.
Basic objectives2
Others
Basic objectives -Others
Changes in hearing performance when wearing supplemental hearing aids or bilateral hearing aids.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Word discrimination in noise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cross-Auditory System
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between the ages of 18 and 75 years old with bilateral profound sensorineural hearing loss and cochlear implantation
Cochlear implant users who have had a cochlear implant for at least 3 months.
The patient developed severe to profound bilateral sensorineural hearing loss after language acquisition.
The patient's first language is Japanese.
Key exclusion criteria
Cochlear implants are worn for less than 3 hours per day.
Hearing loss before language acquisition
The patient's first language is a foreign language.
Other conditions that the physician determines are not appropriate for this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya university
Division name
Medicine, Otorhinolaryngology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2323
tadaoy@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya university
Division name
Medicine, Otorhinolaryngology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2323
Homepage URL
tadaoy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Advanced Bionics, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Ethics Review Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442323
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060459
