UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031478 |
|---|---|
| Receipt number | R000035933 |
| Scientific Title | Exploratory study on word intelligibility evaluation in the presence of competing speech using headphones |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2021/01/28 16:07:57 |
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Basic information
Public title
Exploratory study on word intelligibility evaluation in the presence of competing speech using headphones
Acronym
Evaluation of word intelligibility under competitive speech
Scientific Title
Exploratory study on word intelligibility evaluation in the presence of competing speech using headphones
Scientific Title:Acronym
Evaluation of word intelligibility under competitive speech
Region
| Japan |
Condition
Condition
Normal volunteers and patients with auditory processing disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary study for establishment of objective method to evaluate hearing difficulty in patients with auditory processing disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Word intelligibility test
Interventions/Control_2
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) Normal volunteers: 20 normal volunteers with normal hearing who satisfy the following conditions a) and b)
a) age: 20 <= age < 40 years old
b) Performance status=0 (condition in which daily life can act without any problem)2) Patients with APD: Patients diagnosed as APD (including suspicious cases), among those who intend to participate as volunteers in this study, 20 persons who satisfy the following conditions a), b), c)
a) age: 20 <= age < 40 years old
b) age: 15 <= age < 20 years, adn those who got consent from the parent or guardian for examinationc)
c) Performance status=0 (condition in which daily life can act without any problem)
Key exclusion criteria
Norma subjects
1) A person with a history of ear diseases2) One with a history of mental illness
3) History of peripheral or central neurological disorder
4) Possible pregnancy
5) Those who have judged to be inappropriate as subjects by the researchers
APD subjects
1) Possible pregnancy
2) Those who have judged to be inappropriate as subjects by the researchers
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
1-1 Seiryo-machi, Aoba-ku
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
| 2018 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
26
Results
Word intelligibility under distractors were assesed in normal subjects and patients with suspected auditory processing disorder. Hoowever, it was suggested that it was not suitable for delineating the listening dificulties in the patient group.
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
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
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | 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
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035933
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
