Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061051) titled 'A Study on How Sleep Quality Affects Brain Function the Following Day' on April 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - National Institutes for Quantum Science and Technology

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to examine how changes in sleep quality affect resting-state functional connectivity the following day. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Group A: Pharmaceutical X -> (washout period) -> Food Y Interventions/Control_2 - Group B: Food Y -> (washout period) -> Pharmaceutical X

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - 1. Individuals who have the capacity to provide written informed consent for participation in this study. 2. Male participants aged 18 years or older and under 40 years at the time of consent. 3. Individuals whose habitual caffeine intake is below the recommended amount for healthy adults (<400 mg/day). 4. Individuals who have no abnormalities in sleep or general health status. 5. Individuals who, within the 3 months prior to obtaining consent, have not habitually used tobacco that could affect sleep, have not received any sleep related medical treatment, and have not engaged in shift work or experienced travel across time zones. 6. Individuals judged by a physician (investigator or sub investigator) to have no health problems. Key exclusion criteria - 1. Individuals with a history of serious physical illness or brain disorders in the past or present. 2. Individuals with drug dependence or alcohol dependence. 3. Individuals who are ineligible for MRI examinations(e.g., those with magnetic metal in the body such as tattoos or intraocular lenses, or those with claustrophobia or fear of darkness). 4. Individuals for whom caffeine intake is contraindicated. As a criterion, the description in the package insert of caffeine tablets-such as those regarding heart disease or excessive gastric acid secretion-must be followed. 5. Any other individuals deemed inappropriate as research participants by the physician who is also a researcher. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 03 Day Anticipated trial start date - 2026 Year 04 Month 30 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069857

Disclaimer: Curated by HT Syndication.