UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060185 |
|---|---|
| Receipt number | R000068841 |
| Scientific Title | Dynamic Investigation of Respiratory Status Using Under-Bed Load Cell Sensors in Patients with Various Respiratory Diseases |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/23 22:44:02 |
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Basic information
Public title
Dynamic Investigation of Respiratory Status Using Under-Bed Load Cell Sensors in Patients with Various Respiratory Diseases
Acronym
Dynamic Investigation of Respiratory Status Using Under-Bed Load Cell Sensors in Patients with Various Respiratory Diseases
Scientific Title
Dynamic Investigation of Respiratory Status Using Under-Bed Load Cell Sensors in Patients with Various Respiratory Diseases
Scientific Title:Acronym
Dynamic Investigation of Respiratory Status Using Under-Bed Load Cell Sensors in Patients with Various Respiratory Diseases
Region
| Japan |
Condition
Condition
Respiratory diseases
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate respiratory dynamics in patients with respiratory diseases using under-bed load cell sensors and explore parameters that may serve as indicators of changes in clinical condition.
Basic objectives2
Others
Basic objectives -Others
Investigation of respiratory dynamics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate and tidal volume measured by the bed sensor
Key secondary outcomes
The following parameters measured by the bed sensor were assessed: respiratory instability and respiratory amplitude irregularity; respiratory patterns (including irregular breathing and apnea); heart rate and heart rate irregularity; body weight; body position; presence or absence of bed exit; and body movements.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who fulfils all of the following
1) Written informed consent has been obtained from the patient or a legally authorized representative.
2) The patient is 18 years of age or older at the time of obtaining consent.
3) The patient is admitted to the respiratory medicine ward of our hospital equipped with bed sensors.
Key exclusion criteria
The following individuals will be excluded:
1) Individuals judged by the principal investigator or a co-investigator to be inappropriate for the safe conduct of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Shigeta |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
aya0107@chiba-u.jp
Public contact
Name of contact person
| 1st name | Shizu |
| Middle name | |
| Last name | Miyata |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
Homepage URL
smiyata@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba Cancer Center, Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Observational Research Ethics Committee of Chiba University Hospital
Address
1-8-1 Inohana, Chuo-Ku, Chiba
Tel
0432227171
hsp-kansaturinri@chiba-u.jp
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
| 2026 | Year | 01 | Month | 01 | 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
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Respiratory dynamics in patients with respiratory diseases are observed using under-bed load cell sensors
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068841
