UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029911 |
|---|---|
| Receipt number | R000034168 |
| Scientific Title | The developmen research of biopotential measuring device and autonomatic sleep stage program |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2017/11/10 11:00:16 |
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Basic information
Public title
The developmen research of biopotential measuring device and autonomatic sleep stage program
Acronym
The developmen research of biopotential measuring device and autonomatic sleep stage program
Scientific Title
The developmen research of biopotential measuring device and autonomatic sleep stage program
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yanagisawa Masashi |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
Address
1-1-1 Tennnodai, Tsukuba, Ibaraki
TEL
029-853-3301
yanagisawa.masa.fu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kokubo Toshio |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
Address
1-1-1 Tennnodai, Tsukuba, Ibaraki
TEL
029-853-8080
Homepage URL
kokubo.toshio.fp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, International Institute for Integrative Sleep Medicine
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034168
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
