UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040225 |
|---|---|
| Receipt number | R000045879 |
| Scientific Title | Detection of traveling wave velocity modulation using Chirp evoked brainstem response |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/04/26 09:27:53 |
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Basic information
Public title
Detection of traveling wave velocity modulation using Chirp evoked brainstem response
Acronym
Detection of traveling wave velocity modulation
Scientific Title
Detection of traveling wave velocity modulation using Chirp evoked brainstem response
Scientific Title:Acronym
Detection of traveling wave velocity modulation
Region
| Japan |
Condition
Condition
sudden sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the abnormal travelling wave using auditory brain stem response evoked by Chirp
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amplitude and the latency of wave V evoked by the Chirp and click
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Acute onset hearing disturbance
2) Hearing threshold higher than 30 dB in 3 frequencies, or the total thresholds in 0.125kHz, 0.25kHz, 0.5kHz is larger than 70dB
3) Total thresholds in 0.5, 1, 2kHz is smaller than 210dB
4) No cranial nerve symptoms other than CN VIII
5) Who agreed with the protocol
Key exclusion criteria
1) Who do not agreed with the protocol
2) Who cannot stay rest > 30 min
3) Who has abnormal ear drum
4) Functional or retrocochlear hearing loss
5) Who may be pregnatn
6) Whoc received electrical device implantation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate medical univeristy
Division name
Otolaryngology
Zip code
0283695
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
0196137111
hhiraumi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
0283695
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
0196137111
Homepage URL
hhiraumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
Tel
0196137111
hhiraumi@iwate-med.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 | 07 | 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
| 2020 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the latency and the amplitude of Chirp-evoked brainstem response. The results are analyzed using ANOVA (Chirp vs click, hydrops group vs non-hydrops group vs normal hearing group)
Management information
Registered date
| 2020 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045879
| Research Plan | |
|---|---|
| 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 |
