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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029748
Receipt No. R000033984
Scientific Title Pilot Study on a new contactless device for evaluating sleep state
Date of disclosure of the study information 2017/12/01
Last modified on 2018/10/10

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Basic information
Public title Pilot Study on a new contactless device for evaluating sleep state
Acronym Development of a new contactless sleep study equipment
Scientific Title Pilot Study on a new contactless device for evaluating sleep state
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasunari Miyazaki
Organization Tokyo Medical and Dental University
Division name Center for Pleasant Sleep
Zip code
Address 1-5-45 Yushima, Bukyo-ku, Tokyo
TEL 03-5803-5081
Email miyazaki.pilm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Meiyo Tamaoka
Organization Tokyo Medical and Dental University
Division name Department of Sleep Modulatory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 10 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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