UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011950 |
|---|---|
| Receipt number | R000013956 |
| Scientific Title | Development of a system to easily monitor sleep and respiration at home |
| Date of disclosure of the study information | 2013/10/04 |
| Last modified on | 2015/04/03 09:48:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a system to easily monitor sleep and respiration at home
Acronym
Sleep and respiration monitoring at home
Scientific Title
Development of a system to easily monitor sleep and respiration at home
Scientific Title:Acronym
Sleep and respiration monitoring at home
Region
| Japan |
Condition
Condition
healty subjects
Classification by specialty
| Pneumology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing a system to easily monitor sleep and respiration at home.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of identity for items measured by polysomnography and the new system.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
Those who don't give informed consent.
Those who doctors decided innappropriate for other reasons.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5242
uezapsyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5242
Homepage URL
uezapsyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 10 | Month | 04 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tutility of the simplified system was demonstrated. It is demostrated that the combination of the simple EEG and apnomonitor is able to obtein the similar data as PSG.
Management information
Registered date
| 2013 | Year | 10 | Month | 03 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013956
