UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023308
Receipt No. 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

* 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 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
Email 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
Email shirohisono@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.