UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050933 |
|---|---|
| Receipt number | R000057799 |
| 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 | 2023/04/28 |
| Last modified on | 2023/04/26 13:02:33 |
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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 a program for automatic determination of sleep stages and sleep events with accuracy that can be used for diagnosis of sleep disorders in clinical practice.
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. In addition, to compare objective and subjective data on sleep obtained.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
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
20000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuroh |
| Middle name | |
| Last name | Hiei |
Organization
S'UIMIN Inc.
Division name
Executive Officer
Zip code
151-0061
Address
817 Hatsudai Center Bldg. 1-51-1, Hatsudai, Shibuya-ku
TEL
+81-3-6276-3662
thiei@suimin.co.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Tani |
Organization
S'UIMIN Inc.
Division name
Healthcare Division
Zip code
151-0061
Address
817 Hatsudai Center Bldg. 1-51-1, Hatsudai, Shibuya-ku
TEL
+81-3-6276-3662
Homepage URL
research@suimin.co.jp
Sponsor or person
Institute
S'UIMIN Inc.
Institute
Department
Personal name
Funding Source
Organization
S'UIMIN Inc.
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
Shiba Palace clinic Ethics Committee
Address
DaiwaA Hamamatsucho Building, Hamamatsucho Minato-ku 1-9-10, Tokyo, Japan
Tel
03-5408-1555
jimukyoku@mail.souken-r.com
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
| 2023 | Year | 04 | Month | 28 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057799
