UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028392 |
|---|---|
| Receipt number | R000032506 |
| Scientific Title | Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2024/03/01 23:00:29 |
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Basic information
Public title
Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects
Acronym
Word intelligibility in presence of competing speech
Scientific Title
Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects
Scientific Title:Acronym
Word intelligibility in presence of competing speech
Region
| Japan |
Condition
Condition
1) healthy subjects
2) auditory processing disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary investigation for establishment of objective evaluation of hearing difficulty in patients with auditory processing disorders
Basic objectives2
Others
Basic objectives -Others
Establishment of objective evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Word intelligibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy subjects/Word intelligibility test
Interventions/Control_2
APD patients/Word intelligibility 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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hearing test subjects:
20 subjects with normal hearing participated in the study as a volunteer who agree with the purpose of the research and satisfied the following conditions a) and b)
a) age: 20 years old or older than 20 years, and younger than 40 years old
b)performance status = 0
2)Patients with APD:
20 patients diagnosed with APD (including suspicious cases) who intend to participate as a volunteer in this study and satisfy the following conditions a), b), c)
a) age: 20 years old or older than 20 years, and younger than 40 years old
b) age: 15 years old or older than 15 years, and younger than 20 years old patients who got consent from the parent or guardian for examination
c) Performance status 0
Key exclusion criteria
I) Healthy subjects
1) Past history of the ear disease
2) Subjects with past history of mental disease
3) Subjects with past history of the peripheral or central neurologic disease
4) Subjects with the possibility of the pregnancy
5) Subjects whom researchers judged to be inappropriate
II) patients with APD
1) Subjects with the possibility of the pregnancy
2) Subjects whom researchers judged to be inappropriate
Target sample size
40
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
022-717-8007
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
| 2017 | Year | 07 | Month | 27 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2017 | Year | 07 | Month | 27 | 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=R000032506
