UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031118 |
|---|---|
| Receipt number | R000035536 |
| Scientific Title | Clinical application of ABR in noise in normal population and patients with moderate hearing loss |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/08/08 09:10:21 |
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Basic information
Public title
Clinical application of ABR in noise in normal population and patients with moderate hearing loss
Acronym
ABR in noise
Scientific Title
Clinical application of ABR in noise in normal population and patients with moderate hearing loss
Scientific Title:Acronym
ABR in noise
Region
| Japan |
Condition
Condition
Sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy of ABR in noise to detect hidden hearing loss and moderate sensorineural hearing loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To investigate the prevalence of cochlear synaptopathy in normal hearing population and patients with moderate hearing loss.
2. To establish normal value of wave V latency in ABR in noise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Questionnaire, audiometry, self-recording audiometry, sound-field speech discrimination test, SISI, DPOAE, ABR in noise
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Normal hearing, <20dB
2. Idiopathic sudden hearing loss, healed
3. Meniere's disease
4. Acute low tone loss
5. Tinnitus w/o hearing loss
6. Hyperacusis w/o hearing loss
7. Patients with head and neck cancer undergoing chemotherapy with cisplatin.
Key exclusion criteria
1. Patients with external/middle ear diseases.
2. Patients with hearing loss >40dB in any frequency.
3. Patients in poor general conditions.
4. Minors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Fujikawa |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
fujikawa.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Fujikawa |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
Homepage URL
fujikawa.oto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Address
Tel
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 | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 08 | 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 | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035536
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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