UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043498 |
|---|---|
| Receipt number | R000049661 |
| Scientific Title | Survey on auditory function in healthy subjects |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2021/11/04 15:55:35 |
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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
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
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049661
