Exploratory Study of the Detection of Sleepiness by JINS-MEME in Healthy Adults.

Not Applicable

• Conditions: /A

• Registration Number: JPRN-UMIN000025899
• Lead Sponsor: SOUSEIKAI PS CLINIC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-04
• Study Completion: 2017-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of sleepiness(The algorithm reference)

Secondary Outcome Measures

Name	Time	Method
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)