UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060963 |
|---|---|
| Receipt number | R000069762 |
| Scientific Title | Objective Thresholds of Stress-Induced Tachypnea for Unconscious Stress Detection and Development of a Respiratory Biofeedback System |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/03/17 15:01:23 |
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Basic information
Public title
Objective Thresholds of Stress-Induced Tachypnea for Unconscious Stress Detection and Development of a Respiratory Biofeedback System
Acronym
Objective Thresholds of Tachypnea and Respiratory Biofeedback
Scientific Title
Objective Thresholds of Stress-Induced Tachypnea for Unconscious Stress Detection and Development of a Respiratory Biofeedback System
Scientific Title:Acronym
Objective Thresholds of Tachypnea and Respiratory Biofeedback
Region
| Japan |
Condition
Condition
Stress-related disorders
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish objective thresholds for stress-induced tachypnea by assessing changes in respiratory rate and respiratory amplitude during a mental arithmetic stress task in healthy volunteers, in conjunction with physiological parameters including heart rate variability and skin conductance level. In addition, the feasibility of a system integrating tachypnea detection and vibration-based feedback based on these thresholds will be explored.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Threshold cutoff value for shallow and rapid breathing detection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous measurements of respiratory function (respiratory rate and tidal volume), heart rate, and skin conductance levels will be taken during 5 minutes of rest and 5 minutes of stress induced by a calculation task.
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
This study will be conducted in healthy volunteers.
Key exclusion criteria
1) Individuals currently undergoing medication or outpatient treatment
2) Individuals with mental disorders, such as cognitive impairment, that prevent them from communicating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Department of Psychosomatic Medicine, Kansai Medical University
Division name
Department of Psychosomatic Medicine, Kansai Medical University
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata
TEL
0728040101
h.hasuo7@gmail.com
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-0101
Address
2-5-1-505 Shinmachi, Hirakata
TEL
0728040101
Homepage URL
h.hasuo7@gmail.com
Sponsor or person
Institute
Department of Psychosomatic Medicine, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Psychosomatic Medicine, Kansai Medical University
Address
2-5-1-505 Shinmachi, Hirakata
Tel
0728040101
h.hasuo7@gmail.com
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 | 06 | 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
| 2026 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069762
