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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040225
Receipt No. 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 2020/04/23

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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
Email 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
Email hhiraumi@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 23 Day
Date of IRB
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
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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