UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059492 |
|---|---|
| Receipt number | R000068047 |
| Scientific Title | Analysis of the Impact of Generative AI Feedback on Sleep Quality through Journaling |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/23 06:01:33 |
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Basic information
Public title
Analysis of the impact of generative AI feedback on sleep quality through journaling
Acronym
Analysis of the Impact of Generative AI Feedback on Sleep Quality through Journaling
Scientific Title
Analysis of the Impact of Generative AI Feedback on Sleep Quality through Journaling
Scientific Title:Acronym
Analysis of the Impact of Generative AI Feedback on Sleep Quality through Journaling
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating whether reflective feedback generated by a generative AI on bedtime journaling improves subjective and objective sleep quality.
Basic objectives2
Others
Basic objectives -Others
To examine how reflective feedback generated by a generative AI on a bedtime journal affects sleep quality.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of Sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | 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 sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Momose |
| Middle name | |
| Last name | Kimio |
Organization
Sophia University
Division name
Graduate Degree Program of Applied Data Sciences
Zip code
102-8554
Address
7-1 Kioicho, Chiyoda-ku, Tokyo
TEL
03-3238-3111
k-momose-1ie@sophia.ac.jp
Public contact
Name of contact person
| 1st name | Momose |
| Middle name | |
| Last name | Kimio |
Organization
Sophia University
Division name
Graduate Degree Program of Applied Data Sciences
Zip code
102-8554
Address
7-1 Kioicho, Chiyoda-ku, Tokyo
TEL
03-3238-3111
Homepage URL
k-momose-1ie@sophia.ac.jp
Sponsor or person
Institute
Sophia University
Institute
Department
Personal name
Momose Kimio
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
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 | 10 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068047
