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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name