Clinical Trial: A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use -A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep- (Japan)

Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063295) titled 'A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use -A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep-' on Oct. 16.

Study Type: Interventional

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

Primary Sponsor: Institute - MIS Co.,Ltd.

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

Objective: Narrative objectives1 - The purpose of this study is to exploratorily evaluate changes in usability, acceptability, adherence to use, NeuroTx's proprietary sleep assessment measures, and wearable device integration data following six weeks of WillSleep use in a real-world setting in Japan. In addition, this study aims to collect real-world use data to understand users' experiences and operational challenges in Japan and to assess the potential applicability of WillSleep to the Japanese market. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Wearable Devices

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Japanese men and women aged 20 to 59 at the time of obtaining web consent. 2.Subjects who habitually experience dissatisfaction with their sleep. 3.Subjects who are selected as eligible candidates following a sleep risk assessment using NeuroTx's proprietary sleep assessment questionnaire. 4.Subjects who own a smartphone running Android 10 or later or iOS 15 or later, with Bluetooth Low Energy(BLE)and internet connectivity available, and who are able to complete web-based questionnaires. 5.Subjects whose smartphones are capable of integration with Google Play Services and Health Connect on Android devices, or with Apple Health on iOS devices. 6.Subjects who are able to use WillSleep and the wearable device at home for six weeks during the study period and comply with the procedures specified for the study. 7.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study. Key exclusion criteria - 1.Subjects who have been diagnosed with dementia or who have difficulty adequately understanding the study procedures, informed consent, or instructions for using the study device. 2.Subjects who use a pacemaker. 3.Subjects with heart disease, arrhythmias, or other cardiovascular conditions. 4.Subjects with neurological disorders, such as epilepsy. 5.Subjects who are currently receiving medication or outpatient treatment for any serious medical condition. 6.Subjects who regularly use sleeping pills, anxiolytics, antidepressants, or other medications that may affect sleep. 7.Subjects who have wounds, inflammation, eczema, or other skin conditions at the site where the study device is to be worn, or who have allergies, sensitive skin, or other conditions that may increase the risk of developing dermatitis or other skin reactions due to wearing the study device. 8.Subjects with current or past drug or alcohol dependence. 9.Subjects who are currently receiving medical care for psychiatric disorders(e.g., depression)or sleep disorders(e.g., insomnia or obstructive sleep apnea), or who have a history of psychiatric disorders. 10.Subjects who are currently pregnant or breastfeeding, or who may become pregnant during the study period. 11.Subjects who have difficulty complying with the study procedures, using the application, or completing the scheduled assessments. 12.Subjects who are otherwise deemed ineligible to participate in the study by the principal investigator or the contract research organization for safety-related or study implementation reasons. Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 08 Day Date of IRB - 2026 Year 10 Month 15 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2026 Year 12 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072441

Disclaimer: Curated by HT Syndication.