UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030507 |
|---|---|
| Receipt number | R000034827 |
| Scientific Title | Practical use of sleep EEG for objective assessment and diagnosis of major depression - System evaluation study based on the data from our previous studies - |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2025/02/26 14:13:28 |
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Basic information
Public title
Practical use of sleep EEG for objective assessment and diagnosis of major depression - System evaluation study based on the data from our previous studies -
Acronym
SEEDs Study 2.5
Scientific Title
Practical use of sleep EEG for objective assessment and diagnosis of major depression - System evaluation study based on the data from our previous studies -
Scientific Title:Acronym
SEEDs Study 2.5
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a prediction method for the diagnosis of major depressive disorder by using sleep EEG measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The sleep EEG associated indices assessed in the SEEDs Study 2
Key secondary outcomes
DSM-5 diagnoses
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who underwent the 'SEEDs Study 2 (UMIN000026835)' or 'A study on realization of objective evaluation method of depression using sleep EEG (NCT03133013)'.
Both sleep EEG data and diagnosis of DSM-5 have been fixed.
Participants who underwent the 'Comparative study of 1-channel electroencephalography and polysomnography'.
Key exclusion criteria
None
Target sample size
311
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2291
kadotani@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2291
Homepage URL
kadotani@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Psychiatry, Nihon University
Sleepwell Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.ac.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
| 2017 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
https://amedfind.amed.go.jp/amed/search/task_search_details.html
Publication of results
Unpublished
Result
URL related to results and publications
https://amedfind.amed.go.jp/amed/search/task_search_details.html
Number of participants that the trial has enrolled
238
Results
Several EEG and sleep-related indices may be associated with functional impairment due to depression and psychiatric disorders, according to an analysis of the distribution of SleepScope-measured EEG-related information in depressed and other psychiatric patients and healthy controls.
Results date posted
| 2025 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants in " SEEDs Study 2(UMIN000026835)" and "A Study on the Realization of an Objective Evaluation Method of Depression Using Sleep EEG" who obtained sleep information from 1-channel electroencephalography and DSM-5 diagnoses.
Participants in the study "Comparative study of 1-channel electroencephalography and polysomnography" who obtained sleep information from 1-channel electroencephalography.
Participant flow
The study used existing data collected in previous studies.
Adverse events
Based on the study's use of existing data, adverse events are unlikely.
Outcome measures
Association of sleep EEG measures to DSM-5 diagnoses
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
To verify and modify our predictive model of DSM-5 based MDD diagnosis by using data from the 'SEEDs Study 2 (UMIN000026835)' , 'A study on realization of objective evaluation method of depression using sleep EEG (NCT03133013)' and 'Comparative study of 1-channel electroencephalography and polysomnography'.
Management information
Registered date
| 2017 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034827
