UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029748 |
|---|---|
| Receipt number | 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 22:10:09 |
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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
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
meiyou2.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033984
