臨床研究等提出・公開システム

Scientific Title	Epidemiological Survey for effect of Sleep Disordered Breathing on Attention Deficiency and Hyperactivity among Children 4
Public Title	Child Sleep Survey in Bunkyo City/Higashiyamato City

Contact for Scientific Queries	Investigator Name	Takeshi Tanigawa
	Investigator Organization	Juntendo University
	Address	2-2-5 Hongo, Bunkyo, Tokyo, Japan
	TEL	+81-3-5802-1049
	E-mail	j-koshueisei@juntendo.ac.jp
Contact for Public Queries	Contact Name	Takeshi Tanigawa
	Contact Organization	Juntendo University
	Address	2-2-5 Hongo, Bunkyo, Tokyo, Japan
	TEL	+81-3-5802-1049
	E-mail	j-koshueisei@juntendo.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Sept. 01, 2018
Planned Number of Subjects		1150
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Inventory survey, interventional study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Elementary School students in Bunkyo-Ku and Higashiyamato City
	Exclusion Criteria	No consent to participate in this study
	Minimum Age	6age old over
	Maximum Age	8age old not
	Sex of Participants	Both
Trial Indication(s)		Sleep Disordered Breathing (SDB)
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:Encouragement for possible SDB patients to receive further medical examinations in a hospital Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Prevalence of SDB in community children
Secondary Outcome(s)		Effectiveness of Sensor for Breathing Sound as a screening tool for SDB in community children

Primary Sponsor	Department of Public Health, Graduate School of Medicine, Juntendo University
Secondary Sponsor	Department of Otorhinolaryngology, Juntendo University Faculty of Medicine

Sources of funding	Ministry of Education, Culture, Sports, Science and Technology

Name of Ethics Committee	the Ethics Committee of Juntendo University School of Medicine
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number	18-032
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Aug. 15, 2018

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Secondary Study ID	None
Issuer Name	None

Secondary Study ID	JMA-IIA00401
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Aug. 24, 2020	(this page)	Changes
1	Dec. 11, 2018	Detail

List of change history