UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The developmen research of biopotential measuring device and autonomatic sleep stage program
Title of the study (Brief title)	The developmen research of biopotential measuring device and autonomatic sleep stage program
Region	Japan

Condition
Condition	insomnia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Characteristics of data in one night sleep using the device
Key secondary outcomes	A feeling of wearing, Effect for sleep, Characteristics of data, S/N ratio, polysomnogram (PSG)-equivalence,questionaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The subjects wear the devise and are monitored their sleep. Shortest: 2 days (the duration of observation; 21:00-8:00 next morning) Longest:6 days (the duration of observasion;21:00-8:00 next morning)*3 times
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subject
Key exclusion criteria	Sleep disorder, claustrophobia
Target sample size	100

Research contact person
Name of lead principal investigator	Yanagisawa Masashi
Organization	University of Tsukuba
Division name	International Institute for Integrative Sleep Medicine
Address	1-1-1 Tennnodai, Tsukuba, Ibaraki
TEL	029-853-3301
Email	yanagisawa.masa.fu@u.tsukuba.ac.jp

Public contact
Name of contact person	Kokubo Toshio
Organization	University of Tsukuba
Division name	International Institute for Integrative Sleep Medicine
Address	1-1-1 Tennnodai, Tsukuba, Ibaraki
TEL	029-853-8080
Homepage URL
Email	kokubo.toshio.fp@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba, International Institute for Integrative Sleep Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 11 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 15 Day
Anticipated trial start date	2017 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034168