UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048937 |
|---|---|
| Receipt number | R000055760 |
| Scientific Title | Patch-type EEG and PSG measurements for sleep stage scoring AI system |
| Date of disclosure of the study information | 2022/09/21 |
| Last modified on | 2024/03/18 10:08:42 |
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Basic information
Public title
Patch-type EEG and PSG measurements for sleep stage scoring AI system
Acronym
Patch-type EEG and PSG measurements for sleep stage scoring AI system
Scientific Title
Patch-type EEG and PSG measurements for sleep stage scoring AI system
Scientific Title:Acronym
Patch-type EEG and PSG measurements for sleep stage scoring AI system
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep stage prediction model is developed by EEG acquired by HARU-2 and sleep stages labeled by sleep expert technicians.
Basic objectives2
Others
Basic objectives -Others
Investigation of sleep-stage prediction algorithm
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy (%)
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged 20 to 60 at the time of informed consent
2. BMI is between 18.5 and 25.0
3. PSQI less than 6 (PSQI: Pittsburgh Sleep Questionnaire
4. Usually going to bed between 20:00 and 24:30 and sleeping more than 4 hours a night
Key exclusion criteria
1. Pregnant or breastfeeding
2. Have a disease receiving lifestyle guidance
3. Have sleep disorders (insomnia, hypersomnia, sleep apnea syndrome, etc.)
4. Work at night or shift work
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Shusuke |
| Middle name | |
| Last name | Yoshimoto |
Organization
PGV Inc.
Division name
Engineering Div.
Zip code
103-0027
Address
2-15-5, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
03-6262-7745
yoshimoto@pgv.co.jp
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Yoshimoto |
Organization
PGV Inc.
Division name
Engineering Div.
Zip code
103-0027
Address
2-15-5, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
03-6262-7745
Homepage URL
yoshimoto@pgv.co.jp
Sponsor or person
Institute
PGV Inc.
Institute
Department
Personal name
Funding Source
Organization
PGV Inc., SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
PGV Inc.
Address
2-15-5, Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
03-6262-7745
contact@pgv.co.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
太田睡眠科学センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Observation items
1. PSG data such as electroencephalogram, heart rate, electromyography, electrooculogram, SpO2
2. Sleep stage label
3. SAS Diagnosis Results
4. Electroencephalogram data using HARU-2
5. Age and gender interview results and questionnaire responses
Management information
Registered date
| 2022 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055760
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
