Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060997) titled 'Development of a Relaxation and Music Based Neurofeedback Training Approach' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Healthy Individuals
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study investigates the effects of pre-training-induced alpha-band activity on subsequent increases and enhancements, as well as the duration of these effects, to develop effective techniques for auditory neurofeedback facilitation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Pre-Training and Auditory Neurofeedback Training Intervention
A quiet room in the Human Health Sciences Building will be prepared. One research participant and one researcher will be present in the room. The room will be equipped with an electroencephalography (EEG) device (MUSE), one computer for music playback and data collection, and an iPad for playing instructional videos for the pre-training session. In this quiet environment, the participant will sit in a chair and undergo the pre-training with their eyes closed while following the audio instructions provided in the instructional video. Subsequently, while maintaining the eyes-closed state, the participant will listen to the classical music piece Air on the G String and will be instructed to direct their attention toward perceiving the sound of a babbling stream embedded in the musical background as clearly and for as long as possible. The total duration of each intervention session will be 30 minutes.
Interventions/Control_2 - Auditory Neurofeedback Training Intervention
A quiet room in the Human Health Sciences Building will be prepared. One research participant and one researcher will enter the room. The room will be equipped with an electroencephalography (EEG) device (MUSE) and one computer for music playback and data collection. In this quiet environment, the participant will sit in a chair and, with their eyes closed, listen to the classical music piece Air on the G String. The participant will be instructed to direct their attention toward perceiving the sound of a babbling stream embedded in the musical background as clearly and for as long as possible. The total duration of each intervention session will be 30 minutes.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Students and working adults residing in Kyoto Prefecture.
Normal hearing confirmed for all participants using the Mimi Hearing Test administered on an iPad.
Key exclusion criteria - Prior experience with neurofeedback.
A history of Central and Peripheral Nervous System-related medication use, neurological disorders, psychiatric disorders, respiratory diseases, or cardiovascular diseases.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 19 Day
Anticipated trial start date - 2026 Year 04 Month 01 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=R000069778
Disclaimer: Curated by HT Syndication.