UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059838 |
|---|---|
| Receipt number | R000068431 |
| Scientific Title | Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition |
| Date of disclosure of the study information | 2025/11/22 |
| Last modified on | 2025/11/20 17:31:07 |
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Basic information
Public title
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition
Acronym
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition
Scientific Title
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition
Scientific Title:Acronym
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Continuous Deep Breathing/Aerobic Exercise on Pain Inhibition
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Psychosomatic Internal Medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic pain is a serious global issue, and traditional treatments have limitations such as the need for specialized guidance and the risk of side effects. Therefore, simple approaches that increase neurotransmitters, such as deep breathing and aerobic exercise, have gained attention. Deep breathing activates the brain via the vagus nerve, but its effects tend to be unstable. In contrast, combining it with transcutaneous auricular vagus nerve stimulation (taVNS) may stabilize vagal activity and enhance pain-relieving effects. Aerobic exercise suppresses pain through endogenous opioids, but individuals with chronic pain may find it difficult to continue due to autonomic dysfunction and other factors. However, combining aerobic exercise with taVNS may help maintain autonomic and cognitive function. The aim of this study is to compensate for the limitations of deep breathing and exercise and to examine whether combining them with taVNS can produce stable analgesic effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pressure pain threshold at rest
Key secondary outcomes
heart rate variability, salivary amylase concentration, state-trait anxiety inventory, respiratory rate at rest, accuracy and response time in the Stroop test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will perform deep breathing for 10 minutes per day for 14 days while receiving transcutaneous auricular vagus nerve stimulation on the cymba conchae (continuous deep breathing and active taVNS).
Interventions/Control_2
Participants will perform deep breathing for 10 minutes per day for 14 days while receiving transcutaneous auricular vagus nerve stimulation on the earlobe (continuous deep breathing and sham taVNS).
Interventions/Control_3
Participants will perform deep breathing for 10 minutes once a week for 3 weeks while receiving transcutaneous auricular vagus nerve stimulation on the cymba conchae (weekly deep breathing and active taVNS).
Interventions/Control_4
Participants will perform deep breathing for 10 minutes once a week for 3 weeks while receiving transcutaneous auricular vagus nerve stimulation on the earlobe (weekly deep breathing and sham taVNS).
Interventions/Control_5
Combination of aerobic exercise and transcutaneous auricular vagus nerve stimulation on the cymba conchae (active taVNS).
Interventions/Control_6
Combination of aerobic exercise and transcutaneous auricular vagus nerve stimulation on the earlobe (sham taVNS).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy undergraduate or graduate students
Key exclusion criteria
Individuals with a personal or family history of epilepsy, anxiety disorders, or cardiovascular disease, Pregnant individuals, Individuals experiencing pain, Individuals who exercise three or more times per week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuaki Yamanami, Hirotake Yokota |
| Middle name | Katsuaki, Hirotake |
| Last name | Yamanami, Yokota |
Organization
Graduate School Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Studies
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4500
hpm24005@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Katsuaki Yamanami |
| Middle name | Katsuaki |
| Last name | Yamanami |
Organization
Graduate School Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Studies
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
090-4135-3635
Homepage URL
hpm24005@nuhw.ac.jp
Sponsor or person
Institute
Graduate School Niigata University of Health and Welfare, Graduate School of Medical and Welfare Studies
Institute
Department
Personal name
Funding Source
Organization
Graduate School Niigata University of Health and Welfare, Graduate School of Medical and Welfare Studies
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
Tel
025-257-4500
hpm24005@nuhw.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
| 2025 | Year | 11 | Month | 22 | 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 | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068431
