UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050772 |
|---|---|
| Receipt number | R000057855 |
| Scientific Title | Non-contact measurement of respiration and pulse rate using a piezo-electric sensor sensor on the dental chair |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2024/04/08 16:56:37 |
* 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
Non-contact measurement of respiration and pulse rate using a piezo-electric sensor sensor on the dental chair
Acronym
Non-contact measurement of respiration and pulse rate on the dental chair
Scientific Title
Non-contact measurement of respiration and pulse rate using a piezo-electric sensor sensor on the dental chair
Scientific Title:Acronym
Non-contact measurement of respiration and pulse rate using a piezo-electric sensor sensor on the dental chair
Region
| Japan |
Condition
Condition
Healty adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of non-contact measurement of respiration and pulse rate using a piezoelectric sensor on the dental chair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate measured using a piezoelectric sensor
Key secondary outcomes
Respiratory rate measured using a respiratory inductive plethysmography
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
Key exclusion criteria
1. Respiratory disease with symptoms
2. Facial deformity that makes it difficult to fit a face mask
3. Hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 100 mmHg) or medical treatment for hypertension
4. Arrhythmia or Tachycardia (Pulse rate >= 100 beats/minute)
5. Arteriosclerosis with symptoms or coronary artery disease
6. Orthopedic disorder that makes stair climbing difficult
7. Serious systemic diseases (hepatic, renal, cerebrovascular, cardiovascular, endocrine, etc.) or serious psychiatric disorders.
8. Pregnancy
9. Infectious diseases (hepatitis, syphilis, etc.)
10. Obesity (BMI >= 30)
11. Mobile teeth, non-vital teeth, large dental caries or under treatment in the anterior maxillary region
12. Allergy to resin
13. Other subjects who are estimated inappropriate as research subjects by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
565-0871
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2972
hanamoto.hiroshi.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
565-0871
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2972
Homepage URL
hanamoto.hiroshi.dent@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Hiroshi Hanamoto
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Graduate School of Dentistry General Affairs Section
Address
1-8, Yamadaoka, Suita, Japan
Tel
06-6879-2831
si-soumu-syomu@office.osaka-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
| 2023 | Year | 04 | Month | 06 | 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
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject is lie in a dental chair with a piezoelectric sensor.
Respiratory rate is measured using the RIP and the piezoelectric sensor under the condition of the respiratory rate of 6-28 breaths per minute and the tidal volume of approximately 5-15 ml/kg.
Investigate the correlation of the measurement value of between respiratory rate using piezoelectric sensor and taht using the RIP.
After exercise load for 3 minutes on the master two-step, pulse rate is measured using the piezoelectric sensor and pulse oximeter.
Investigate the correlation of the measurement value of between pulse rate using the piezoelectric sensor and that using the pulse oximeter.
A resin block is be placed on the anterior maxillary teeth to examine the effect of vibration caused by dental instruments on the measured value of respiration rate and pulse rate using the piezoelectric sensor.
Dental instruments is used through a resin block that is placed on the anterior maxillary teeth.
Examine the effect of vibration caused by dental instruments on the measured value of respiration rate and pulse rate using the piezoelectric sensor.
In addition, the correlation between the RIP waveform and the tidal volume measured by the spirometer is investigated.
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057855
