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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044205
Receipt No. R000050466
Scientific Title Development of an algorithm for automatic sleep staging using electroencephalography (EEG) measurement devices and observation of the state and progress of sleep in an environment at home
Date of disclosure of the study information 2021/05/13
Last modified on 2021/05/13

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Basic information
Public title Development of a sleep staging algorithm for electroencephalography (EEG) devices and observation of sleep in an environment at home
Acronym Development of a sleep staging algorithm for electroencephalography (EEG) devices and observation of sleep in an environment at home
Scientific Title Development of an algorithm for automatic sleep staging using electroencephalography (EEG) measurement devices and observation of the state and progress of sleep in an environment at home
Scientific Title:Acronym Development of an algorithm for automatic sleep staging using electroencephalography (EEG) measurement devices and observation of the state and progress of sleep in an environment at home
Region
Japan

Condition
Condition Sleep disorder including insomnia, sleep apnea syndrome, etc
Healthy people
Classification by specialty
Pneumology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study 1: To develop an reliable automatic sleep staging program.
Study 2: To confirm that characteristic state and progress of sleep can be ovserved by the measurement of EEG and other bioelectric potentials using the EEG device at home.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Study 1: An agreement rate between results of sleep staging by the automated sleep staging program and clinical laboratory technicians certified by the Japanese Society of Sleep Research.
Study 2: Preparation of hypnograms of subjects based on the sleep staging by using EEG data obtained with the EEG device and the automated sleep staging program, and extraction/evaluation of characteristics of their sleep from the hypnograms.
Key secondary outcomes Longitudinal changes in sleep variables e.g., total sleep time, sleep onset time, sleep efficiency, (indexes of adaptation to the EEG measurement device) and intra-week variations (an index of sleep regularity).

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

Not applicable
Gender Male and Female
Key inclusion criteria Sleep disorder including insomnia, sleep apnea syndrome,etc.
Healthy people
Key exclusion criteria Minor:under 20 years old
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Fujiwara
Organization S'UIMIN Inc.
Division name Representative Director
Zip code 151-0061
Address 817 Hatsudai Center Bldg. 1-51-1, Hatsudai, Shibuya-ku
TEL +81-3-6276-3662
Email mfujiwara@suimin.co.jp

Public contact
Name of contact person
1st name Tetsuroh
Middle name
Last name Hiei
Organization S'UIMIN Inc.
Division name Business Strategy and Development
Zip code 151-0061
Address 817 Hatsudai Center Bldg. 1-51-1, Hatsudai, Shibuya-ku
TEL +81-3-6276-3662
Homepage URL
Email thiei@suimin.co.jp

Sponsor
Institute S'UIMIN Inc.
Business Strategy and Development
Institute
Department

Funding Source
Organization S'UIMIN Inc.
Business Strategy and Development
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Cykinso Research Ethics Committee
Address Odaka Building, Yoyogi Shibuya 1-36-1, Tokyo, Japan
Tel 03-5309-2522
Email science@cykinso.co.jp

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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 13 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
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 Open public recruiting
Date of protocol fixation
2020 Year 06 Month 18 Day
Date of IRB
2020 Year 06 Month 18 Day
Anticipated trial start date
2020 Year 06 Month 18 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 05 Month 13 Day
Last modified on
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050466

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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