UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044647 |
|---|---|
| Receipt number | R000050977 |
| Scientific Title | Development of a new biopotential measurement device and automatic sleep staging program |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2022/12/26 17:55:39 |
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Basic information
Public title
Development of a new biopotential measurement device and automatic sleep staging program
Acronym
Development of a new biopotential measurement device and automatic sleep staging program
Scientific Title
Development of a new biopotential measurement device and automatic sleep staging program
Scientific Title:Acronym
Development of a new biopotential measurement device and automatic sleep staging program
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using a simple sleep monitor in this study, it is possible to perform sleep tests on a large number of subjects without using polysomnography (PSG), which is the standard method used to diagnose sleep disorders. This method can be used to diagnose sleep disorders. This method is highly needed by patients, as it allows for a very simple diagnosis of many patients with suspected sleep disorders.
Basic objectives2
Others
Basic objectives -Others
(1) We will evaluate the wearability of the EEG and other biopotential measurement devices (EEG measurement devices made by S'UIMIN Co., Ltd.) developed by S'UIMIN Co., Ltd. and their effects on sleep, data characteristics in the operating environment, and signal-to-noise ratio. The study will be conducted on 200 healthy subjects. The study design is a prospective study, an interventional study that does not fall under the category of "preventive, diagnostic, or therapeutic methods using drugs or medical devices. It is an open-label, single study.
By developing a S'UIMIN EEG measurement device and an automatic sleep staging program with sufficient accuracy to diagnose sleep disorders in clinical practice, it will be possible for anyone to receive a highly accurate sleep measurement test easily at home with low burden and cost in the future. This will make it possible for anyone to receive a highly accurate sleep measurement test at home at a low cost and low burden.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) We will evaluate the EEG measurement device made by S'UIMIN Co., Ltd. in terms of wearability, effect on sleep, data characteristics in use environment, and signal-to-noise ratio. Furthermore, a performance verification test will be conducted by simultaneous measurement with PSG, and the characteristics and accuracy of each biological signal will be compared with the standard method to evaluate the equivalence.
2) Visual sleep staging will be performed by a clinical laboratory technician certified by the Japanese Society of Sleep Research after data acquisition of biometric information obtained from S'UIMIN's EEG measurement device and polysomnography EEG, electroretinogram, electromyogram, etc. collected during normal sleep and parameters such as lights-out time. The result is taken as the correct answer, and the judgment accuracy and agreement rate are calculated.
3) We will begin development of a program to automatically perform sleep staging by analyzing biopotential data such as EEG during sleep, referring to existing data from PSG tests and simple electroencephalographs. We will optimize the algorithm, the structure of the analysis system, and the analysis parameters, etc., in order to improve the judgment accuracy and agreement rate by comparing the analysis results of the program with those of clinical technologists certified by the Japanese Society of Sleep Research.
4) Once the judgment accuracy and agreement rate reach the target, optimize the algorithm, the structure of the analysis system, and the analysis parameters in order to improve the accuracy and agreement rate of the sleep staging judgment of the data acquired using the EEG measurement device manufactured by S'UIMIN Co.
Key secondary outcomes
Waking Sleep Awareness Questionnaire (MA version)
At what time did you fall asleep last night?
At what time did you wake up this morning?
How many hours of sleep did you get last night?
Example
Entry date: Monday
ID:
I'm still tired I'm not tired
Entry field
1. tiredness remains tiredness is gone
2. I have concentration I have no concentration
3. had a good sleep did not have a good sleep
4. feeling liberated feeling stressed
5. my body feels lazy my body feels crisp
6. have an appetite have no appetite
7. was out of bed a lot before falling asleep was out of bed a little before falling asleep
8. clear-headedness fuzzy-headedness
9. had many nightmares had no nightmares
10. had a good night's sleep had a bad night's sleep
11. felt uncomfortable felt refreshed
12. dreamed a lot dream a little
13. woke up a lot during sleep did not wake up during sleep
14. can answer a survey quickly now answering is troublesome
15. had a long sleep had a short sleep
16. slept lightly slept deeply
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
This is an interventional study that does not fall under the category of preventive, diagnostic, or therapeutic methods using drugs or medical devices.
The duration of the intervention is one day. The amount of intervention is wearing the device only, the number of interventions is one time, and the frequency is one night.
Interventions/Control_2
This is an interventional study that does not fall under the category of preventive, diagnostic, or therapeutic methods using drugs or medical devices.
The duration of the intervention is one day. The amount of intervention is wearing the device only, the number of interventions is one time, and the frequency is one night.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will be included in the following all criteria.
1) Having no difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2) No claustrophobia and being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba.
3) Having no sleep disorder currently being treated
4) Having no hearing impairment in daily life
5) High scores of State-Trait Anxiety Inventory - subscale scores of trait anxiety (45-80 point)
Key exclusion criteria
Participants will be excluded from the experiment based on the following criteria.
1)BMI less than 18.5 or greater than 25
2)Worked night shifts (after 10pm) 3 months prior to the experiment
3) Travel across time zones with time
Difference of 3 hours or more, 3 months prior to the experiment
4) Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more)
5)Smoker
6) Consumes more than 400 mg (Based on the maximum caffeine intake of healthy adults without adverse effects [European Food Safety Authority, Health Canada],5 cups of 150mL) of coffee every day
7) MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
8) Those who cannot perceive the auditory stimulation and feel uncomfortable when listening to samples of this experiment.
9) Pregnancy or its possibility
10) Lactation
11) Those who have a disease that may change suddenly or its history
12) Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated
13)Candidates of Participants who follow all inclusion criteria, but exclusion criteria 1) -12) will be reported to psychiatrist. Psychiatrist interviews as needed to determine the unsuitable person as a subject.
14) Subjects judged by the principal investigator to be inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yanagisawa |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298533853
nishimura.atsushi.gn@un.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Fukusumi |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298532786
Homepage URL
fukusumi.shoji.fw@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
International Institute for Integrative Sleep Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address
Amakubo, Tsukuba, Ibaraki 305-5876, Japan
Tel
029-853-3914
jisedai@md.tsukuba.ac.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
筑波大学高精細医療イノベーション棟（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 24 | 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
| 2021 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050977
