UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062499 |
|---|---|
| Receipt number | R000071452 |
| Scientific Title | Non-contact respiratory and heart rate monitoring on a dental chair using a millimeter-wave sensor |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/06 20:04:14 |
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Basic information
Public title
Non-contact respiratory and heart rate monitoring on a dental chair using a millimeter-wave sensor
Acronym
Non-contact respiratory and heart rate monitoring on a dental chair using a millimeter-wave sensor
Scientific Title
Non-contact respiratory and heart rate monitoring on a dental chair using a millimeter-wave sensor
Scientific Title:Acronym
Non-contact respiratory and heart rate monitoring on a dental chair using a millimeter-wave sensor
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the accuracy and clinical feasibility of non-contact respiratory and heart rate monitoring using millimeter-wave sensors mounted on a dental chair by comparing the measurements with those obtained using conventional monitoring devices.
Basic objectives2
Others
Basic objectives -Others
To evaluate the minimum observation time required for estimating respiratory rate and heart rate using millimeter-wave radar sensors and to compare their performance with that of piezoelectric sensors. In addition, the effects of vibrations from dental instruments and body movements on measurement accuracy will be investigated, and the feasibility of using these signals as an indicator of tidal volume will be explored.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate (agreement between measurements obtained using millimeter-wave radar sensors and respiratory inductive plethysmography [RIP])
Key secondary outcomes
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who voluntarily provide written informed consent to participate in the study.
Key exclusion criteria
Symptomatic respiratory disease
Facial deformities that make placement of an anesthesia face mask difficult
Hypertension or treatment with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=100 mmHg)
Arrhythmia or tachycardia (heart rate >=100 beats/min)
Symptomatic atherosclerosis or coronary artery disease
Orthopedic disorders that make stair climbing difficult
Severe systemic diseases (including hepatic, renal, cerebrovascular, cardiovascular, and endocrine disorders) or severe psychiatric disorders
Pregnancy or possible pregnancy
Infectious diseases (e.g., hepatitis or syphilis)
Obesity (body mass index [BMI] >=30 kg/m^2)
Mobility, extensive caries, non-vital teeth, or ongoing treatment in the maxillary anterior region
Resin allergy
Dental phobia
Any condition judged by the principal investigator to make participation in the study inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Dental Anesthesiology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL
082-257-5785
h-hanamoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Dental Anesthesiology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL
082-257-5785
Homepage URL
h-hanamoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyocera Corporation
Name of secondary funder(s)
Kyocera Corporation
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
Tel
082-257-5907
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 08 | Month | 07 | 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 | 10 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study involving healthy volunteers. Respiratory rate and heart rate measured using millimeter-wave radar and piezoelectric sensors will be compared with those obtained using conventional monitoring devices under simulated dental treatment conditions. The effects of body movement, dental instrument vibrations, and observation time on measurement accuracy will be evaluated. Signal characteristics will also be explored.
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071452
