UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061006 |
|---|---|
| Receipt number | R000069810 |
| Scientific Title | Objective Evaluation of Fatigue in Endoscopy Healthcare Providers Using Heart Rate Variability Analysis with Wearable Devices |
| Date of disclosure of the study information | 2026/03/30 |
| Last modified on | 2026/03/21 19:36:05 |
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Basic information
Public title
Objective Evaluation of Fatigue in Endoscopy Healthcare Providers Using Heart Rate Variability Analysis with Wearable Devices
Acronym
Wearable-based Evaluation and Assessment of Fatigue
Scientific Title
Objective Evaluation of Fatigue in Endoscopy Healthcare Providers Using Heart Rate Variability Analysis with Wearable Devices
Scientific Title:Acronym
Wearable-based Evaluation and Assessment of Fatigue
Region
| Japan |
Condition
Condition
Musculoskeletal Disorders
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess physiological markers reflecting physical and mental workload during endoscopic procedures using wearable devices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To quantitatively evaluate changes in physiological parameters, including heart rate variability, pulse wave, and acceleration, in healthcare providers during endoscopic procedures, as measured using wearable devices and Holter electrocardiography, by comparing values before, during, and after the procedures.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear a wearable device and Holter electrocardiography during endoscopic procedures to continuously measure physiological parameters, including heart rate variability.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Physicians, nurses, or clinical engineers working at our institution
2. Scheduled to be engaged in endoscopic procedures, including colonoscopy, ERCP, EUS-FNA, or ESD
3. Able to wear the measurement devices (wearable device and Holter electrocardiography) for a specified period
4. Provided written informed consent to participate in the study
Key exclusion criteria
1. Individuals with cardiovascular disease or autonomic dysfunction that may affect heart rate variability assessment
2. Individuals who are regularly taking medications that affect heart rate or autonomic nervous system function
3. Individuals for whom wearing the measurement devices is difficult or inappropriate due to skin conditions or allergies
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
0592321111
aiji-h@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Aiji |
| Middle name | |
| Last name | Hattori |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
0592321111
Homepage URL
aiji-h@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
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
Mie University Graduate School of Medicine
Address
2-174, Edobashi, Tsu, Mie
Tel
0592321111
aiji-h@med.mie-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 | 03 | Month | 30 | 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 | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069810
