Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061291) titled 'Evaluation of the effects of an AI-based sleep service' on April 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - EUPHORIA Co., Ltd.
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effectiveness of an AI-based sleep service for improving sleep among workers using a randomized controlled trial design.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will use an AI-based sleep service that provides:
1) personalized behavioral recommendations tailored to regular shift cycles and transitions;
2) weekly AI-generated feedback based on these recommendations;
3) automated data-entry reminders; and
4) AI-powered Q&A support and assistance with data interpretation.
Interventions/Control_2 - No intervention
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Healthy men and women aged 18 years or older.
2. Employees of a company (including both day-shift and shift workers).
3. Shift workers with a regular rotating shift schedule.
Key exclusion criteria - 1. Individuals who have difficulty operating computers or smartphones at a level comparable to healthy individuals.
2. Individuals who participated in another clinical trial within the past month, or plan to participate in other clinical research after providing consent for this study.
3. Individuals with a history of, or current, serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, or cardiovascular disease).
4. Individuals currently receiving medical treatment for any disease, or those with a history of serious illness requiring medication.
5. Individuals unable to refrain from starting new use of health foods (including supplements affecting the cardiovascular system or metabolism), quasi-drugs, over-the-counter (OTC) drugs, or external analgesics/anti-inflammatory agents (such as poultices) during the study period.
6. Others judged ineligible for the study by their primary physician or the principal investigator.
Target Size - 35
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 24 Day
Date of IRB - 2026 Year 03 Month 24 Day
Anticipated trial start date - 2026 Year 05 Month 08 Day
Last follow-up date - 2027 Year 05 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069764
Disclaimer: Curated by HT Syndication.
