Tokyo, Oct. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059492) titled 'Analysis of the impact of generative AI feedback on sleep quality through journaling' on Oct. 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Sophia University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Investigating whether reflective feedback generated by a generative AI on bedtime journaling improves subjective and objective sleep quality.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - The intervention period consists of seven consecutive nights from the start of the intervention.
For seven consecutive days, participants write a journal in diary format before bedtime.
After each entry, the generative AI immediately provides listening-oriented feedback (e.g., summaries, emotion labeling, empathic responses).
Interventions/Control_2 - For seven consecutive days, participants write a journal in diary format before bedtime.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Healthy adults under 60 years of age who understand the purpose of the study and that they may withdraw from participation at any time without disadvantage.
Key exclusion criteria - Individuals aged 17 years or younger, or 60 years or older
Individuals diagnosed with a mental disorder by a physician
Individuals regularly taking prescription medications such as sleeping pills
Cases in which the researcher judges that participation may adversely affect the participant's physical or mental condition
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 30 Day
Date of IRB - 2025 Year 10 Month 07 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068047
Disclaimer: Curated by HT Syndication.