Unique ID issued by UMIN | UMIN000025899 |
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Receipt number | R000029777 |
Scientific Title | Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults. |
Date of disclosure of the study information | 2017/02/04 |
Last modified on | 2017/03/24 16:01:13 |
Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults.
Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults.
Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults.
Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults.
Japan |
N/A
Psychiatry |
Others
NO
To study the accuracy of detecting daytime sleepiness of the glasses-type wearable device, JINS-MEME, the JINS-MEME and the PSG (the typical method to evaluate the sleep-awake cycle) will be tested with the same subjects simultaneously.
Others
To establish an evaluation method for the objective detection of sleepiness and to improve the analysis algorithm of JINS-MEME, the glasses type wearable device.
Others
Others
Not applicable
Assessment of sleepiness(The algorithm reference)
Sleepiness assessment using the PolymateMini (objective reference)
ECG(C3, C4, O1, 2): alfa waves / beta waves
EOG (Vertical): Changes in the Bell's phenomenon, Blink count
EOG (Horizontal): gradual pupil movement
Subjective sleepiness by subjects (10 point VAS Scale)
Observational
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Subjects who are defined by the PI/SI as able to understand and comply with the study.
2. Subjects who are able to sign their name and date on the informed consent form before the study is started.
3. Subjects who are healthy Japanese adults.
4. Subjects who are from 20 to 65 years old at the time they sign the IC.
1. Subjects who are found to be as ineligible by the PI/SI for measurement of the JINS-MEME or PSG that are going to be used in this study.
2. Subjects who are found to be unable to participate in the study due to conditions that are uncontrollable and clinically problematic due to abnormalities of nerves, the cardiovascular system, lungs, liver, kidneys, metabolic system, GI system, urology, endocrinology, psychiatric or other abnormalities.
3. Subjects who are defined as unable to abstain from drugs that have arousal properties or from subjects' personal preferences (including caffeine & nicotine), which might affect the results of the measurements.
4. Subjects who are found by the PI/SI to be seemingly unable to comply with the study protocol or ineligible for other reasons
10
1st name | |
Middle name | |
Last name | Megumi Inoue |
SOUSEIKAI PS Clinic
Clinical Research Division
8F Random Square,6-18 Tenyamachi, Hakata-ku, Fukuoka City, Fukuoka 812-0025 Japan
0922831115
megumi-inoue@lta-med.com
1st name | |
Middle name | |
Last name | Hiroko Kumashiro |
SOUSEIKAI PS Clinic
Clinical Research Division
8F Random Square,6-18 Tenyamachi, Hakata-ku, Fukuoka City, Fukuoka 812-0025 Japan
0922831115
hiroko-kumashiro@lta-med.com
SOUSEIKAI PS CLINIC
Takeda Pharmaceutical Company Limited
Profit organization
JAPAN
NO
医療法人相生会 ピーエスクリニック (福岡県)
2017 | Year | 02 | Month | 04 | Day |
Unpublished
Subjective sleepiness and arousal level in JINS-MEME and drowsiness judgment of Polymate mini and JINS-MEME were compared. In objective judgment, beta, alfa, theta, spindle and cranial peak acute waves were judged in EEG, Bell phenomenon REM due to blinking by slow blinking eye and slowly decelerated eye movement (SEM) were judged with EOG as clues. As a result, when the electric potential change of the eye movement clearly appears, the judgment result tends to match.
Completed
2017 | Year | 01 | Month | 13 | Day |
2017 | Year | 02 | Month | 04 | Day |
2017 | Year | 02 | Month | 28 | Day |
JINS-MEME and PolymateMini for EEG and EOG are used together to measure sleepiness reference until the subject falls asleep or for 40 minutes under the condition stated in Maintenance of wakefulness test (MWT).
VAS scale is used to record subjective sleepiness.
2017 | Year | 01 | Month | 30 | Day |
2017 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029777
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