Tokyo, June 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061796) titled 'Effects of binaural beats on physiological responses' on June 4.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - University of Tsukuba

Condition: Condition - Healthy subject Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare EEG, heart rate, and respiratory responses between 0.25 Hz and control stimulus during quiet wakefulness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A.250 Hz presented to both ears (control, no beat) B.250-250.25 Hz (0.25 Hz binaural beats) The order of the conditions is (A, B). Interventions/Control_2 - The order of the conditions is (B, A).

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Participants will be included based on the following all criteria. 1)Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms 2)Being able to come to the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba without disrupting their normal daily rhythm 3)Living a regular life between 21:00-1:00 bedtime and 6:00-9:00 wake-up 4)Having no sleep disorder currently being treated 5)Having no hearing impairment in daily life Key exclusion criteria - Participants will be excluded from the experiment based on the following criteria. 1)Irregular lifestyle (Regular: sleep time between 9:00 p.m. and 1:00 a.m., wake time between 6:00 a.m. and 9:00 a.m.) 2)BMI less than 18.5 or greater than 25 3)Worked night shifts (after 10:00 p.m.) 3 months prior to the experiment 4)Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment 5)regular consumes alcohol (40g (2 cans of beer) or more twice a week or more) 6)Smoker habit 7)Consumes more than 300mg (5 cups of 150mL) of coffee per day 8)MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type) 9)Pittsburgh Sleep Quality Index score greater than 5.5 10)Cannot perceive the frequency difference of the binaural beats and feel uncomfortable when listening to the auditory stimulation samples of this experiment 11)Claustrophobic 12)Pregnancy or its possibility 13)Breastfeeding 14)Having a disease that may change suddenly or its history 15)Having been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated 16)Deemed inappropriate by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 07 Day Date of IRB - 2026 Year 05 Month 07 Day Anticipated trial start date - 2026 Year 05 Month 28 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070615

Disclaimer: Curated by HT Syndication.