Healthy subjects
Conditions
Interventions
None listed
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.) | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed