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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042981
Receipt No. R000049069
Scientific Title The hearing rehabilitation using ADHEAR for unilateral hearing loss
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/13

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Basic information
Public title The hearing rehabilitation using ADHEAR for unilateral hearing loss
Acronym The hearing rehabilitation using ADHEAR for unilateral hearing loss
Scientific Title The hearing rehabilitation using ADHEAR for unilateral hearing loss
Scientific Title:Acronym The hearing rehabilitation using ADHEAR for unilateral hearing loss
Region
Japan

Condition
Condition unilateral sensorineural hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To provide the opportunity to experience the ADHEAR for unilateral sensorineural hearing loss patients
Basic objectives2 Others
Basic objectives -Others Experience the use of ADHEAR
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The hearing test before an after using ADHEAR
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)the averaged hearing level>70 dBHL in bad side and < 30 dBHL in good side
2)normal skin behind the ear
3)age between 20-74, without the diagnosis of dementia
4)agreement with the use of ADHEAR
Key exclusion criteria 1)abnormal skin behind the ear
2)functional or retrocochlear hearing loss
3)disagreed to the use of ADHEAR
4)Other judged as inappropriate
Target sample size 12

Research contact person
Name of lead principal investigator
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
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 岩手医科大学附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 13 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 11 Month 28 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To provide the opportunity to experience the ADHEAR for unilateral sensorineural hearing loss patients

Management information
Registered date
2021 Year 01 Month 12 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049069

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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