UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017210 |
|---|---|
| Receipt number | R000019031 |
| Scientific Title | A study of a complex sound auditory brain stem response (cABR) for patients with hearing loss |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2023/04/29 12:06:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of a complex sound auditory brain stem response (cABR) for patients with hearing loss
Acronym
A study of a complex sound auditory brain stem response (cABR) for patients with hearing loss
Scientific Title
A study of a complex sound auditory brain stem response (cABR) for patients with hearing loss
Scientific Title:Acronym
A study of a complex sound auditory brain stem response (cABR) for patients with hearing loss
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The ABR measurement for the hearing loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An evaluation by speech-evoked ABR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
normal hearing
Interventions/Control_2
hearing loss
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
| 19 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
It is 80 years old from 20 years old
Key exclusion criteria
Less than 19 years old and 81 years old or older
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of Medicine
Division name
Otolaryngology
Zip code
1600016
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
0333531211
shokanza@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of Medicine
Division name
Otolaryngology
Zip code
1600016
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
0333531211
Homepage URL
shokanza@gmail.com
Sponsor or person
Institute
Keio University School of Medicine Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Otolaryngology
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
Keio University School of Medicine
Address
35 Shinanomachi Shinjyuku-ku Tokyo
Tel
03-3451-8211
okamotoy.10@kdt.biglobe.ne.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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
10.1016/j.heares.2019.03.016
Number of participants that the trial has enrolled
25
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
| 2015 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | 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
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019031
