UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042981
Receipt number 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 2021/03/06 13:30:00

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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 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

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

Enrolling by invitation

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 03 Month 06 Day



Link to view the page

Value
https://center6.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