Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062313) titled 'Study on the Effects of Listening to 40Hz Amplitude-Modulated Sounds on Gamma-Band Brain Wave' on July 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - National Institute of Advanced Industrial Science and Technology (AIST)
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the effects of long-term listening to 40 Hz modulated sounds on gamma-band EEG activity in healthy older adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Listening to music stimuli subjected to 40 Hz amplitude modulation (1 hour daily for a total of 180 days).
Interventions/Control_2 - Listening to music stimuli subjected to noise-addition processing (1 hour daily for a total of 180 days).
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - (1) Individuals capable of providing written informed consent to participate in the study of their own free will
(2) Individuals aged 65 to 74 years at the time of obtaining consent
(3) Gender: No restriction
Key exclusion criteria - (1) Individuals with hearing impairment
(2) Individuals with depression or anxiety disorders (diagnosed with depression/anxiety disorders or currently taking antidepressants/anxiolytics) or those with a GDS-15 score of 5 or higher
(3) Individuals with dementia (diagnosed with dementia or currently taking dementia medication) or those with an MMSE score of 27 or lower
(4) Individuals diagnosed with epilepsy or currently taking medication for epilepsy
(5) Individuals who self-report having a mental disorder such as schizophrenia spectrum disorder or bipolar disorder
(6) Individuals who self-report having a developmental disorder such as autism spectrum disorder or attention-deficit/hyperactivity disorder (ADHD)
(7) Individuals unable to properly undergo EEG measurement and psychological testing
(8) Individuals with a history of routine use of commercially available products that play 40 Hz modulated sounds
(9) Any other individuals deemed unsuitable by the principal investigator or co-investigators
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 13 Day
Date of IRB - 2026 Year 07 Month 16 Day
Anticipated trial start date - 2026 Year 07 Month 24 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071309
Disclaimer: Curated by HT Syndication.