UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot Study on a new contactless device for evaluating sleep state
Title of the study (Brief title)	Development of a new contactless sleep study equipment
Region	Japan

Condition
Condition	Sleep apnea syndrome
Classification by specialty	Medicine in general Cardiology Pneumology Neurology Psychiatry Laboratory medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess accuracy of a new sheet-shaped sensor under development and a wearable sensor comparing with traditional polysomnography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	concordance rate between a new sensor and traditional PSG
Key secondary outcomes

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	One night traditional PSG with contactless sheet-shaped sleep sensor and wearable sensor
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult male and female
Key exclusion criteria	In case that consent can not be gained
Target sample size	5

Research contact person
Name of lead principal investigator	Yasunari Miyazaki
Organization	Tokyo Medical and Dental University
Division name	Center for Pleasant Sleep
Address	1-5-45 Yushima, Bukyo-ku, Tokyo
TEL	03-5803-5081
Email	miyazaki.pilm@tmd.ac.jp

Public contact
Name of contact person	Meiyo Tamaoka
Organization	Tokyo Medical and Dental University
Division name	Department of Sleep Modulatory Medicine
Address	1-5-45 Yushima, Bukyo-ku, Tokyo
TEL	03-5803-5954
Homepage URL
Email	meiyou2.pulm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Sensor & IoT consortium
Organization
Division
Category of Funding Organization	Non profit foundation
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	東京医科歯科大学

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 29 Day
Anticipated trial start date	2017 Year 12 Month 01 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 10 Month 29 Day
Last modified on	2018 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033984