UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

N/A

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -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.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Assessment of sleepiness(The algorithm reference)

Key secondary outcomes

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key 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.

Key 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

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Megumi Inoue

Organization

SOUSEIKAI PS Clinic

Division name

Clinical Research Division

Zip code

Address

8F Random Square,6-18 Tenyamachi, Hakata-ku, Fukuoka City, Fukuoka 812-0025 Japan

TEL

0922831115

Email

megumi-inoue@lta-med.com

Name of contact person

1st name
Middle name
Last name	Hiroko Kumashiro

Organization

SOUSEIKAI PS Clinic

Division name

Clinical Research Division

Zip code

Address

8F Random Square,6-18 Tenyamachi, Hakata-ku, Fukuoka City, Fukuoka 812-0025 Japan

TEL

0922831115

Homepage URL

Email

hiroko-kumashiro@lta-med.com

Institute

SOUSEIKAI PS CLINIC

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人相生会　ピーエスクリニック　（福岡県）

Date of disclosure of the study information

2017

Year

02

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

13

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

04

Day

Last follow-up date

2017

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

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.

Registered date

2017

Year

01

Month

30

Day

Last modified on

2017

Year

03

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029777