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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033010
Receipt No. R000037633
Scientific Title Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Date of disclosure of the study information 2018/08/01
Last modified on 2019/02/24

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Basic information
Public title Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Acronym Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Scientific Title Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Scientific Title:Acronym Clinical significance of the perception on external auditory meatus evoked by portable peripheral nerve stimulator
Region
Japan

Condition
Condition sensorineural hearing loss, facial palsy, chronic otitis externa, and chronic otitis media
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluation of electrically evoked sensory threshold on external auditory meatus before and after treatment in each disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes electrically evoked sensory threshold on external auditory meatus three months after the treatment
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Before treatment, electrically evoked sensory threshold in external auditory meatus is measured using portable peripheral nerve stimulator. Three months (and 6 months, if possible) after the initial treatment, reexamination is performed in the same way.
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

Not applicable
Gender Male and Female
Key inclusion criteria those who were diagnosed sensorineural hearing loss, facial palsy, chronic otitis media, and chronic otitis externa in our hospital
Key exclusion criteria those who are suffering from active otitis media, wet condition of external auditory canal due to inflammation, and external auditory canal stenosis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Tono
Organization University of Miyazaki
Division name Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine
Zip code
Address 5200 kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL +81-985-85-2966
Email otorhino@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Nakashima
Organization University of Miyazaki
Division name Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine
Zip code
Address 5200 kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL +81-985-85-2966
Homepage URL
Email otorhino@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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 08 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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2019 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2019 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037633

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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