Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059555) titled 'A study to develop a monitoring system that measures changes in finger movements and warns about excessive drinking' on Jan. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Healthy adult volunteers under alcohol exposure Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - During alcohol consumption, characteristic changes in finger movement will be detected using a finger motion measurement device. This information will be used to evaluate alterations in finger movements during smartphone operation under drinking conditions. Based on these data, we will develop a smartphone application equipped with a machine learning-based intoxication detection function and an alert/warning function. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants are healthy adults (>19 years old) who undergo baseline assessment in a sober state, including questionnaires on drinking habits and addiction screening, vital signs, and motor task performance. Each participant then consumes alcohol according to their usual drinking style after light food intake to avoid fasting intake. Every 30 minutes, until predefined stopping criteria are met (or up to 3 hours), the following are repeatedly assessed: peripheral oxygen saturation (SpO2), blood pressure, subjective intoxication score, single-leg standing time, Timed Up and Go (TUG) test, breath alcohol concentration, and two app-based motor tasks (handwriting tracing on a tablet and thumb-movement game on a smartphone). The pre-alcohol (sober) measurements serve as the within-subject control condition, and data obtained during alcohol exposure are compared against this baseline to evaluate intoxication-related changes in fine finger motion.

Eligibility: Age-lower limit - 20 years-old 19 years at the time of consent. Able to provide written informed consent for study participation. Habitual alcohol consumption of at least once per month under usual conditions. Key exclusion criteria - History of trauma to the upper limbs or cervical spine Presence of neuromuscular disease, peripheral neuropathy, or any condition that affects finger motor function Severe alcohol use disorder/ alcohol dependence, past history of alcohol abuse, or screening positive for dependence or suspected dependence on an alcohol dependence screening questionnaire Pregnancy or breastfeeding Ongoing psychiatric treatment, or continuous use of psychotropic medication (e.g., antipsychotics, benzodiazepines) Hepatic dysfunction, or a history of diseases or pharmacological treatments that substantially affect alcohol metabolism Low alcohol tolerance as determined by saliva-based DNA testing Inability to rest on the morning following the experimental session Living alone Deemed unsuitable for participation by the principal investigator or subinvestigators Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 27 Day Anticipated trial start date - 2026 Year 03 Month 30 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068119

Disclaimer: Curated by HT Syndication.