UMIN-CTR Clinical Trial

Basic information
Public title	Survey on auditory function in healthy subjects
Acronym	Survey on auditory function in healthy subjects
Scientific Title	Survey on auditory function in healthy subjects
Scientific Title:Acronym	Survey on auditory function in healthy subjects
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the conditions such as age and eveluation methods for the healthy subject group who are "aware of deterioration of the auditory function".
Basic objectives2	Others
Basic objectives -Others	Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire for hearing 2002,Japanese version Hearing disability and handicap scale,Japanese version Hearing Handicap Inventory for Adults or Hearing Handicap Inventory for the Elderly,MMSE-J,Japanese version BDI-2,Adult Autism Spectrum Disorders Self-Rating Scale,Adult Attention-Deficit Hyperactivity Disorder Self-Rating Scale,Wechsler Adult Intelligence Scale-Third Edition,Visual Analog Scale,Various hearing tests(Pure tone hearing measurement,Hearing in Noise Test-Japanese,J-matrix test,67S Threshold measurement,Speech discrimination measurement,Time information processing measurement, etc.)
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	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy Japanese men and women aged between 30 and 70 at the time of obtaining written consent. 2.Subject who is aware of poor listening. 3.Subject with BMI>=18.5 and <25. 4.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Key exclusion criteria	1.Subject who has received a diagnosis (auditory processing disorder) related to deafness or abnormal hearing function by a doctor or a medical examination. 2.Subject who uses hearing aids. 3.Subject who has been or are prone to dementia in the past. 4.Subject who has been or are prone to depression in the past. 5.Subject who is attends the hospital due to mental or sleep disorders or have a history of mental illness in the past. 6.Subject who has or are prone to autism spectrum disorders, attention deficit hyperactivity disorder / attention deficit hyperactivity disorder in the past. 7.Subject who is currently undergoing medication or outpatient treatment due to some serious illness. 8.Subject who is currently exercising or dieting under the supervision of a doctor. 9.Subject with current or history of drug or alcohol dependence. 10.Subject with irregular life rhythms due to night shifts or shift work. 11.Subject who has extremely irregular eating or sleeping habits. 12.Subject who has an extremely unbalanced diet. 13. Subject who has serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease. 14.Subject who uses health foods, supplements, and medicines that affect hearing 15.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 16.Subject who is judgedas an inappropriate candidate from test results at the time of the SCR. 17.Others who are judged by the research institute to be inappropriate candidates.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	non-disclosure
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.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	2021 Year 03 Month 03 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	Completed
Date of protocol fixation	2021 Year 02 Month 22 Day
Date of IRB	2021 Year 02 Month 25 Day
Anticipated trial start date	2021 Year 03 Month 24 Day
Last follow-up date	2021 Year 07 Month 20 Day
Date of closure to data entry	2021 Year 07 Month 29 Day
Date trial data considered complete	2021 Year 07 Month 29 Day
Date analysis concluded	2021 Year 11 Month 02 Day

Other
Other related information	Exploratory research

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049661