UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023308 |
|---|---|
| Receipt number | R000026858 |
| Scientific Title | Accuracy verification of a biological monitor with load-cell sensors under the bed and exploratory analyses of its clinical usefulness |
| Date of disclosure of the study information | 2016/07/24 |
| Last modified on | 2018/12/03 20:04:15 |
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Basic information
Public title
Accuracy verification of a biological monitor with load-cell sensors under the bed and exploratory analyses of its clinical usefulness
Acronym
Accuracy verification of a biological monitor with load-cell sensors under the bed
Scientific Title
Accuracy verification of a biological monitor with load-cell sensors under the bed and exploratory analyses of its clinical usefulness
Scientific Title:Acronym
Accuracy verification of a biological monitor with load-cell sensors under the bed
Region
| Japan |
Condition
Condition
Adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve and validate accuracy of biological information obtained with load-cell sensors under the bed by comparing it with polysomnographic data
Basic objectives2
Others
Basic objectives -Others
To explore potential usefulness of the load-cell sensors for improving patient care
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory rate
Key secondary outcomes
tidal volume, the number of breathing abnormalities, pulse rate, blood pressure, sleep, arousal, and other exploratory parameters
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults recruited by public invitation at the web-site of Department of Anesthesiology, Graduate School of Medicine, Chiba University.
2. Both subjects with and without clinical symptoms of sleep disordered breathing
Key exclusion criteria
Subjects who are unable to sleep on bed with polysomnographic sensors
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of medicine, Chiba University
Division name
Anesthesiology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL
043-222-7171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of Medicine, Chiba University
Division name
Anesthesiology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Minebea Co., LtD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 07 | Month | 24 | 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
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In adult human volunteers who are on a bed with load-cell sensors under the bed, we perform standard full polysomnographic recordings including electroencephalograms, electrooculograms, electromyograms of the submental and leg muscles, electrocardiogram, airflow measurement with a nasal pressure prong and a oro-nasal thermistor, thoracoabdominal wall motions with piezo respiratory effort sensors, oxygen saturation (SpO2), snoring over a microphone, and body position. We improve and validate the accuracy of biological parameters obtained by the load-cell sensors by comparing them with the data obtained by the polysomonography. Furthermore, we will explore potential usefulness of the load-cell sensors for improving patient care.
Management information
Registered date
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026858
| 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 |
