None listed
Conditions
Interventions
None listed
Sponsors
SOUSEIKAI PS CLINIC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of sleepiness(The algorithm reference) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHiroko Kumashiro
SOUSEIKAI PS Clinic Clinical Research Division
Outcome results
None listed