UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048489 |
|---|---|
| Receipt number | R000055034 |
| Scientific Title | Phonemic restoration on patients with implantable hearing prostheses : comparison between cochlear implants, middle ear implants, and electric acoustic stimulation cochlear implantation |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2022/07/27 17:58:26 |
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Basic information
Public title
Phonemic restoration on patients with implantable hearing prostheses
Acronym
Phonemic restoration on implantable hearing device users
Scientific Title
Phonemic restoration on patients with implantable hearing prostheses : comparison between cochlear implants, middle ear implants, and electric acoustic stimulation cochlear implantation
Scientific Title:Acronym
Phonemic restoration on the users of CI, MEI, and EAS
Region
| Japan |
Condition
Condition
sensorineural hearing loss, mixed/conductive hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is determining effects for phonemic restoration by different kinds of implantable hearing prostheses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correct answer rate for the phonemic restoration examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Listening of phoemic restration sentence test.
Interventions/Control_2
Listening of not phonemic restration sentence test.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjests of this study can listen monosylalbic words better than 50%.
Key exclusion criteria
Those are excluded who have cognitive impairment which make doing test difficulty.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masae |
| Middle name | |
| Last name | Shiroma |
Organization
Graduate school, International University of Health and Welfare
Division name
Ootawara campus
Zip code
324-8501
Address
2600-1 Kitakanemaru, Ootawara, Tochigi.
TEL
0287-24-3000
mshiroma@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masae |
| Middle name | |
| Last name | Shiroma |
Organization
Graduate school, International University of Health and Welfare
Division name
Ootawara campus
Zip code
324-8501
Address
2600-1 Kitakanemaru, Ootawara, Tochigi.
TEL
0287-24-3000
Homepage URL
mshiroma@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare.
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, International University of Health and Welfare.
Address
4-1-26 Akasaka, Minato-ku, Tokyo.
Tel
03-5574-3900
rinri-tky@iuhw.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
| 2022 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055034
