Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062293) titled 'Sleep in Older Adults Undergoing Driver's License Renewal' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Older adults undergoing driver's license renewal Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine the prevalence of sleep-disordered breathing, a risk factor for motor vehicle accidents, and to investigate the association between sleep status and driving behavior (including accident risk) in older drivers undergoing driver's license renewal. Participants will undergo home-based polysomnography (PSG) and complete questionnaires on sleep and driving behavior. Basic objectives2 - Others

Eligibility: Age-lower limit - 70 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Able to receive and return the study device by postal mail. (2) Able to communicate by telephone in Japanese. (3) Able to scan a QR code and view a video explaining the use of the study device using a smartphone or similar device, either independently or with assistance from a family member or caregiver. (4) No apparent safety concerns that would preclude participation in the study. Key exclusion criteria - (1) Individuals with psychiatric disorders or psychiatric symptoms that, in the opinion of the investigator, would make participation in the study difficult. (2) Individuals who are not expected to be able to undergo home-based polysomnography (PSG) within 3 months after driver's license renewal. (3) Individuals currently receiving treatment for sleep-disordered Breathing (SDB), including continuous positive airway pressure (CPAP) therapy. (4) Individuals with a cardiac pacemaker. (5) Individuals receiving home oxygen therapy. (6) Individuals undergoing deep brain stimulation (DBS) for Parkinson's disease. (7) Individuals with epilepsy. Target Size - 500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 23 Day Date of IRB - 2026 Year 04 Month 23 Day Anticipated trial start date - 2026 Year 06 Month 23 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=R000071285

Disclaimer: Curated by HT Syndication.