UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060746 |
|---|---|
| Receipt number | R000069504 |
| Scientific Title | Development of a Predictive Model and Biomarker Exploration for Sleep Disorders Based on Multidimensional Physiological Time-Series Data |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/25 13:02:19 |
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Basic information
Public title
Study on Prediction and Biomarker Exploration of Sleep Disorders Using Physiological Data
Acronym
PBE-SLEEP Study
Scientific Title
Development of a Predictive Model and Biomarker Exploration for Sleep Disorders Based on Multidimensional Physiological Time-Series Data
Scientific Title:Acronym
MD-PBE Study
Region
| Japan |
Condition
Condition
Sleep Disorders
Classification by specialty
| Neurology | Psychiatry | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop an artificial intelligence (AI) model that automatically estimates clinical test results and questionnaire assessments using multidimensional physiological time-series data obtained from overnight polysomnography (PSG) and multiple sleep latency test (MSLT) recordings. Feature contribution analyses will also be conducted to visualize the model's decision-making process, in order to explore the potential application of explainable AI (XAI) for diagnostic support and early detection of sleep disorders.
Basic objectives2
Others
Basic objectives -Others
Development of an AI-based predictive model for sleep disorders and evaluation of its explainability.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-validated predictive performance of sleep disorder estimation models (accuracy, sensitivity, specificity, area under the curve (AUC), mean absolute error (MAE), and root mean square error (RMSE).
Key secondary outcomes
Quantification of the contribution of each physiological signal and temporal segment to model predictions using feature attribution analysis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals whose multidimensional physiological time-series data, including PSG and MSLT recordings, were obtained at National Center Hospital, National Center of Neurology and Psychiatry between January 2013 and January 31, 2026.
Key exclusion criteria
Individuals who have declined the use or disclosure of their medical information. For minors, those who have declined such use or disclosure, or whose legally authorized representatives have declined on their behalf.
Target sample size
4400
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo, Japan
TEL
042-346-2014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Fukazawa |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo, Japan
TEL
042-346-2014
Homepage URL
ukazawa@sophia.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
/ National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8553, Japan
Tel
042-341-2712
rinri-jimu@ncnp.go.jp
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 | 02 | Month | 27 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 20 | 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
Associations between multidimensional physiological time-series data derived from PSG and MSLT, and clinical test results and questionnaire assessments will be analyzed to develop an AI model. Feature attribution analyses will be conducted to visualize the model's decision-making process, thereby exploring the potential application of explainable AI for diagnostic support and early detection of sleep disorders.
Management information
Registered date
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069504
