UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063145 |
|---|---|
| Receipt number | R000072262 |
| Scientific Title | A Prospective Observational Study on Variations and Prediction of Mental and Physical States in Daily Life Using Smartphone Behavioral Logs and Activity Data |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 10:01:09 |
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Basic information
Public title
A Prospective Observational Study on Variations and Prediction of Mental and Physical States in Daily Life Using Smartphone Behavioral Logs and Activity Data
Acronym
A Prospective Observational Study on Variations and Prediction of Mental and Physical States in Daily Life Using Smartphone Behavioral Logs and Activity Data
Scientific Title
A Prospective Observational Study on Variations and Prediction of Mental and Physical States in Daily Life Using Smartphone Behavioral Logs and Activity Data
Scientific Title:Acronym
A Prospective Observational Study on Variations and Prediction of Mental and Physical States in Daily Life Using Smartphone Behavioral Logs and Activity Data
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To continuously collect smartphone behavioral logs passively obtained in daily life, information related to sleep-wake rhythms and physical activity obtained from an activity monitor, and daily subjective data on mental and physical states, and to integrate and analyze these data to identify features associated with within-person variations in mental and physical states, including sleep, sleepiness, fatigue, mood, and stress, and to examine the feasibility of estimating and predicting these states. In addition, statistical and machine-learning methods will be used to develop estimation and prediction models that account for within-person variations and between-person differences.
Basic objectives2
Others
Basic objectives -Others
Exploration of features associated with within-person variations in mental and physical states and development of models for estimating and predicting these states.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Performance of models for estimating daily mental and physical states and their within-person variations, including subjective sleep quality, restorative sleep, sleepiness, fatigue, mood, and stress assessed using daily questionnaires, from smartphone behavioral logs.
Key secondary outcomes
1. Associations between behavioral indices derived from smartphone behavioral logs and subjective measures assessed by daily questionnaires, including subjective sleep quality, restorative sleep, sleepiness, fatigue, mood, stress, and pain.
2. Associations between behavioral indices derived from smartphone behavioral logs and objective measures of sleep-wake rhythms obtained from an activity monitor.
3. Scores on questionnaires administered before and at the end of the measurement period (PHQ-9, POMS, PSQI, MEQ, ESS, SHPS, AIS, ISI, HAS, TIPI, UWES, SPQ, SWLS, UCLA, and SAS-SV), their associations with smartphone behavioral logs, activity-monitor data, and daily questionnaires, and the feasibility of estimating and predicting sleep and mental and physical states using these questionnaire scores.
4. Comparison of the performance of estimation models based on group-level data with models adjusted using individual-level data.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 18 years or older and younger than 70 years at the time of informed consent.
2. Individuals who routinely use their own Android smartphone and are able to install and use the study data collection application on the device during the study period.
3. Individuals who are able to wear an activity monitor and complete the questionnaires and daily questionnaires during the 14-day study period.
4. Individuals who are able to provide written informed consent to participate in the study.
Key exclusion criteria
1. Individuals engaged in shift work including night shifts.
2. Individuals who regularly use psychotropic medications or sleep medications.
3. Individuals who have traveled across one or more time zones within the three months prior to the start of the study.
4. Individuals otherwise judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Toho University
Division name
Faculty of Human Health
Zip code
465-8515
Address
3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan
TEL
052-782-1724
suimin.study@gmail.com
Public contact
Name of contact person
| 1st name | Michitaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Toho University
Division name
Faculty of Human Health
Zip code
465-8515
Address
3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan
TEL
052-782-1724
Homepage URL
suimin.study@gmail.com
Sponsor or person
Institute
Aichi Toho University
Institute
Department
Personal name
Michitaka Yoshimura
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
i2medical LLC
Name of secondary funder(s)
Japan Society for the Promotion of Science (JSPS)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 10 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study methods
This is a 14-day prospective observational study conducted in daily life. Participants will install a study application on their own Android smartphones to collect behavioral logs and will wear an activity monitor to collect data on sleep-wake rhythms and physical activity. They will also complete daily questionnaires in the morning and evening and questionnaires before and at the end of the measurement period. The collected data will be analyzed using statistical and machine-learning methods to explore features associated with within-person variations in mental and physical states and to develop estimation and prediction models.
Recruitment
Participant recruitment will be partially outsourced to SOUKEN Co., Ltd. Written informed consent will be obtained from all participants.
Measurements
A) Smartphone behavioral logs: location, screen/device usage, application usage, acceleration, steps, and movement/activity status. Contents of messages, emails, calls, typed text, audio, photographs, and videos will not be collected.
B) Activity monitor: sleep-wake rhythms and physical activity.
C) Questionnaires: sleep, sleepiness, fatigue, mood, stress, and other mental and physical states.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072262
