UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057012 |
|---|---|
| Receipt number | R000065160 |
| Scientific Title | Accuracy and Utility of Various Wearable Devices for Sleep Assessments |
| Date of disclosure of the study information | 2025/02/16 |
| Last modified on | 2025/02/13 13:35:40 |
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Basic information
Public title
Validation Study of Sleep Measurements Using Various Wearable Devices
Acronym
Validation of Sleep Measurements Using Wearable Devices
Scientific Title
Accuracy and Utility of Various Wearable Devices for Sleep Assessments
Scientific Title:Acronym
Accuracy and Utility of Sleep-Related Data from Wearable Devices
Region
| Japan |
Condition
Condition
Participants who stay at a capsule hotel operated by nine hours Inc. and undergo a polysomnography (PSG) test at the same hotel.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the accuracy and utility of sleep evaluation by wearable devices through comparison with simultaneously recorded PSG measurements.
Basic objectives2
Others
Basic objectives -Others
Evaluation of accuracy and utility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance rate for sleep duration
Key secondary outcomes
-Concordance rate for each sleep variable
Sleep variables from PSG (using test data obtained within nine hours Inc.'s business operations):
Sleep efficiency, Sleep latency, Wake time after sleep onset, Stage N1 time, Stage N2 time, Stage N3 time, Stage REM time.
Sleep variables from wearable devices:
Sleep efficiency, Sleep latency, Wake time after sleep onset, Sleep stage variables*
*Since sleep stage display methods differ for each wearable device, appropriate comparison methods will be selected for each device (e.g., wearable device "Light" sleep time vs. PSG Stage N1+N2, wearable device "Deep" sleep time vs. PSG Stage N3, etc.)
-Concordance rate for Sleep-Related Breathing Disorder Variables:
Apnea-hypopnea index, Blood oxygen saturation level, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who will stay at a capsule hotel run by Nine Hours Inc. undergo PSG testing and consent to participate in this research.
Key exclusion criteria
Those deemed unsuitable by the research director.
Target sample size
300
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
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Utsumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
Homepage URL
t-utsumi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Kenichi Kuriyama
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
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
国立精神・神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 16 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
-Study Design: Prospective observational study
-Subject recruitment method: Recruitment will target individuals who will stay at capsule hotels run by nine hours Inc. and undergo polysomnography (PSG) testing at the hotels from February 17, 2025, to March 31, 2027.
-Evaluation Items: Refer to Primary and Secondary Outcome Measures.
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065160
