UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042332 |
|---|---|
| Receipt number | R000048325 |
| Scientific Title | Exploratory research to establish a test method for assessing auditory attention disorder |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2024/03/01 23:04:30 |
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Basic information
Public title
Exploratory research to establish a test method for assessing auditory attention disorder
Acronym
Exploratory research to establish a test method for assessing auditory attention disorder
Scientific Title
Exploratory research to establish a test method for assessing auditory attention disorder
Scientific Title:Acronym
Exploratory research to establish a test method for assessing auditory attention disorder
Region
| Japan |
Condition
Condition
auditory processing disorder
tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The basic data necessary to visualize the impaired auditory attention mechanism will be accumulated exploratively, and the test method and test conditions to assess the insufficiency of the auditory attention mechanism will be established.
Basic objectives2
Others
Basic objectives -Others
assessment of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent correct for frequency discrimination task
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) normal subjects with no history of ear disease or neurological / neurological disease2) Patients diagnosed as auditory iprocessing disorder
3) Tinnitus patients with a THI score of 40 or higher
Key exclusion criteria
(1) Nonmal subject
1) Those with a history of ear disease
2) Those with a history of mental illness3) Those with a history of peripheral or central nervous system diseases
4) Those who are pregnant or may become pregnant
5) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects
(2) Auditory processing disorder / tinnitus patients
1) Those who are pregnant or may become pregnant
2) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
kawase@orl.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
Homepage URL
kawase@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology-Japan
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2020 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study on evaluation of auditory attention in normal subjects and patient groups (patients with auditory processing disorder and tinnitus patients)
Management information
Registered date
| 2020 | Year | 11 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048325
