UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy verification of a biological monitor with load-cell sensors under the bed and exploratory analyses of its clinical usefulness
Title of the study (Brief title)	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	Shiroh Isono
Organization	Graduate School of medicine, Chiba University
Division name	Anesthesiology
Address	Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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