Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063397) titled 'Evaluation of the utility of pupillary oscillation as an objective indicator of alertness' on Oct. 26.

Study Type: Observational

Primary Sponsor: Institute - Tohoku University

Condition: Condition - adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the association between pupillary oscillation recorded during the Psychomotor Vigilance Test (PVT) and PVT performance in adults, and to determine whether pupillary oscillation can serve as an objective indicator of alertness. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1)Adults aged 18 years or older at the time of informed consent. 2)Individuals who can visit the study site. 3)Individuals who voluntarily provide written informed consent to participate in the study. 4)Individuals who can cooperate with physical activity and sleep monitoring using monitoring devices under daily living conditions. Key exclusion criteria - 1)Individuals with ocular diseases, iris abnormalities, or other conditions that interfere with accurate pupil measurements. 2)Individuals who have difficulty recognizing the visual stimuli or performing the PVT because of impaired visual function or other reasons. 3)Individuals in whom heart rate variability cannot be appropriately measured or analyzed because of a pacemaker or other conditions. 4)Individuals who have difficulty undergoing physical activity and sleep monitoring using monitoring devices under daily living conditions. 5)Individuals taking hypnotics, psychotropic medications, or other medications that may affect sleep, alertness, or pupillary responses. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 14 Day Date of IRB - 2026 Year 10 Month 20 Day Anticipated trial start date - 2026 Year 11 Month 09 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072563

Disclaimer: Curated by HT Syndication.