UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application of the simplified electroencephalograph in a clinical setting
Title of the study (Brief title)	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	Akihito Uezato
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Psychiatry and Behavioral Sciences
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5242
Email	uezapsyc@tmd.ac.jp

Public contact
Name of contact person	Akihito Uezato
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Psychiatry and Behavioral Sciences
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5242
Homepage URL
Email	uezapsyc@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University Faculty of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018938