UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045833 |
|---|---|
| Receipt number | R000051860 |
| Scientific Title | The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2025/05/02 15:33:17 |
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Basic information
Public title
The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar
Acronym
The clinical trial by ultra-wideband radar
Scientific Title
The clinical trial to verify accuracy for measuring respiratory and heart rates and respiratory events by ultra-wideband (UWB) radar
Scientific Title:Acronym
The clinical trial by ultra-wideband radar
Region
| Japan |
Condition
Condition
patients with suspected sleep disordered breathing (SDB)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify accuracy for measuring respiratory and heart rates and respiratory events by UWB radar with smartphone, comparing the data with the parameters by polysomnography (PSG) or portable monitoring
Basic objectives2
Others
Basic objectives -Others
To verify the equivalence of respiratory and heart rates and respiratory events by UWB radar with smartphone and those by PSG or portable monitoring
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The equivalence of respiratory and heart rates and respiratory events (RE) by UWB radar with smartphone and those by PSG or portable monitoring.
Key secondary outcomes
Comparison of respiratory rate and respiratory events during sleep measured by between smartphone and PSG or portable monitoring.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurements of respiratory and heart rate by UWB radar with smartphone,PSG, or portable monitoring simultaneously.
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
Patients who are suspected to have sleep disordered breathing (SDB)
Key exclusion criteria
1.Patients who were already diagnosed as sleep apnea syndrome and treated.
2. Physically disabled patients
3.Patients who refuse to participate in this trial
4.Patients who are judged as inappropriate candidates by the doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Nihon University of Medicine
Division name
Department of Sleep Medicine and Respiratory Care Division of Sleep Medicine Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo
TEL
03-3972-8111
chin.kazuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Hoshi |
Organization
Graduate school of medicine, Nihon university
Division name
Respitory medicine
Zip code
173-8610
Address
30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo
TEL
03-3972-8111
Homepage URL
mema21005@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University of Medicine
Institute
Department
Personal name
Funding Source
Organization
1.Japan Agency for Medical Research and Development
2. KYOTO Industrial Support Organization 21
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinjuku Sleep and Respiratory Medicine Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University of Medicine
Address
30-1 Oyaguchi kamicho Itabashi-ku Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.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
| 2021 | Year | 10 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Prospective observational study
Research to determine usefulness and accuracy in measurements of respiratory and heart rates by ultra-wideband radar
Outcomes will be evaluated at
1) The first admission
2) The second admission
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051860
