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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031118
Receipt No. 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 2018/02/02

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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
Email 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
Email fujikawa.oto@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
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
2018 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035536

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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