UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025011 |
|---|---|
| Receipt number | R000028776 |
| Scientific Title | Development of objective assessments for the auditory processing disorders. |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2020/05/31 10:47:13 |
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Basic information
Public title
Development of objective assessments for the auditory processing disorders.
Acronym
Development of objective assessments for the auditory processing disorders.
Scientific Title
Development of objective assessments for the auditory processing disorders.
Scientific Title:Acronym
Development of objective assessments for the auditory processing disorders.
Region
| Japan |
Condition
Condition
Auditory processing disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the efficient electrophysiological audiometry for the auditory processing disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electrophysiological audiometry
Evoked potential inspection
Event related potential
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient Group:The objects who have hearing problems.
Control Group:The objects who have no hearing problems.
Key exclusion criteria
The objects who have diagnosed as organic hearing loss.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwai |
Organization
Kansai Medical University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata-City, Osaka, Japan.
TEL
072-804-0101
iwai@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Ashitani |
Organization
Shiga University
Division name
Department of Education
Zip code
520-0862
Address
2-5-1 Hiratsu, Otsu-city, Shiga, Japan.
TEL
077-537-7769
Homepage URL
amichiko@edu.shiga-u.ac.jp
Sponsor or person
Institute
Kansai Medical Univesity
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Research Ethics Committee
Address
2-3-1 Shinmachi, Hirakata-City, Osaka, Japan.
Tel
072-804-2551
rinriirb@hirakata.kmu.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
| 2017 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the developed system, we could record the P300 by using the 67-S word tone. P300 was measured when the SN ratio was 10 dB and 5 dB, but disappeared at 0 dB.
Management information
Registered date
| 2016 | Year | 11 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028776
