UMIN-CTR Clinical Trial

Basic information
Public title	Hearing function under the noise -evaluation in normal volunteer-
Acronym	Hearing function under the noise -evaluation in normal volunteer-
Scientific Title	Hearing function under the noise -evaluation in normal volunteer-
Scientific Title:Acronym	Hearing function under the noise -evaluation in normal volunteer-
Region	Japan

Condition
Condition	normal function
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of the normal range concerning the hearing function in noise to evaluate the hearing difficulty of the person with hearing loss
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	speech intelligibility
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	auditory function
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	normal volunteer (20 <= age < 40, and the performance status=0)
Key exclusion criteria	1) past history of peripheral and/or central neurologic disease 2) past history of ear disease 3) past history of mental disease 4) Pacemaker and/or implanted defibrillator 5) cerebral aneurysm clip, a bolt and a plate after the bone fracture treatment, the correction of the tooth, tattoo, hairdye for less than one month 6) claustrophobia, scotophobia 7) the possible pregnancy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tetsuaki Middle name Last name Kawase
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Email	kawase@orl.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Tetsuaki Middle name Last name Kawase
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Homepage URL
Email	kawase@orl.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku 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	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo-machi, Aoba-ku
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 02 Day

Related information
URL releasing protocol	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	12
Results	Twelve subjects (24 ears) with normal hearing were examined auditory function tests such as speech intelligibility testing under noise, and normal values for subjects with normal hearing were evaluated.
Results date posted	2021 Year 01 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	normal volunteer
Participant flow	Open call for participants
Adverse events	none
Outcome measures	speech intelligibility in noise
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 02 Day
Date of IRB	2016 Year 12 Month 08 Day
Anticipated trial start date	2016 Year 12 Month 02 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028883