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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025899
Receipt No. 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

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Basic information
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
Condition N/A
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute SOUSEIKAI PS CLINIC
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人相生会 ピーエスクリニック (福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 04 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
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

Progress
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
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.

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2017 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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