UMIN-CTR Clinical Trial

Basic information
Public title	Development of a hearing screening method
Acronym	a hearing screening method
Scientific Title	Development of a hearing screening method for people with hearing loss
Scientific Title:Acronym	a hearing screening method
Region	Japan

Condition
Condition	Hearing loss
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop a screening method for hearing loss in the living environment.
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between sound listening and changes in biological responses.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in heart rate
Key secondary outcomes	Heart rate in rest

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Listening to sound
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Normal hearing no hyperacusis
Key exclusion criteria	20 years old > 60 years old <= hearing loss hyperacusis
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Oishi
Organization	Keio University
Division name	School of Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	0353633827
Email	oishin@keio.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Oishi
Organization	Keio University
Division name	School of Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	0353633827
Homepage URL
Email	oishin@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University Global Research Institute
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	0333531211
Email	keio@esct.bvits.com

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 26 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	2021 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 25 Day
Last modified on	2021 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050433