UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016316 |
|---|---|
| Receipt number | R000018938 |
| Scientific Title | Application of the simplified electroencephalograph in a clinical setting |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2018/07/27 11:31:50 |
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Basic information
Public title
Application of the simplified electroencephalograph in a clinical setting
Acronym
Application of the simplified EEG in a clinical setting
Scientific Title
Application of the simplified electroencephalograph in a clinical setting
Scientific Title:Acronym
Application of the simplified EEG in a clinical setting
Region
| Japan |
Condition
Condition
healthy subjects
patients with sleep disorders
patients with mental illness
Classification by specialty
| Pneumology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine if the simplified EEG could obtain data comparable to that obtained by PSG from patients with sleep disorders.
2. To examine if the simplified EEG could detect changes in signals in patients with mental illness.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concordance rates in sleep stages
frequencies in EEG
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
2 patients with sleep disorders
5 patients with mental illness
5 healthy subjects
Key exclusion criteria
Those who don't give informed consent.
Those who doctors decided inappropriate for
other reasons.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
uezapsyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
Homepage URL
uezapsyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Analysis of EEG
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
