UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062277 |
|---|---|
| Receipt number | R000071241 |
| Scientific Title | Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing on Neck Shoulder Muscle Activity and Autonomic Responses During a Typing Task |
| Date of disclosure of the study information | 2026/07/23 |
| Last modified on | 2026/07/19 22:33:20 |
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Basic information
Public title
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing on Neck Shoulder Muscle Activity and Autonomic Responses During a Typing Task
Acronym
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing on Neck Shoulder Muscle Activity and Autonomic Responses During a Typing Task
Scientific Title
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing on Neck Shoulder Muscle Activity and Autonomic Responses During a Typing Task
Scientific Title:Acronym
Effects of Concurrent Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing on Neck Shoulder Muscle Activity and Autonomic Responses During a Typing Task
Region
| Japan |
Condition
Condition
healthy adults and adults with mild neck pain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the temporal changes in neck and shoulder muscle activity and autonomic nervous system activity during a typing task and to examine the association between these variables.
Basic objectives2
Others
Basic objectives -Others
To compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS), deep breathing, and their combination on neck and shoulder muscle activity and autonomic nervous system activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bilateral upper trapezius muscle activity
Autonomic nervous system activity
Key secondary outcomes
Cervical range of motion (ROM)
Tenderness threshold (PPT)
Subjective fatigue (Borg scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous auricular vagus nerve stimulation (taVNS)
Stimulation site: Effective stimulus: Left auricle; Stimulus: Left earlobe
Stimulation frequency: 80Hz
Stimulation pattern: 6 seconds ON / 4 seconds OFF
Duration: 30 minutes
Interventions/Control_2
Deep breathing
Inhalation: Through the nose
Exhalation: Through the mouth
Breathing pattern: 4 seconds inhalation / 6 seconds exhalation
Interventions/Control_3
Transcutaneous Auricular Vagus Nerve Stimulation and Deep Breathing
Stimulation Site: Left auricle, left earlobe
Stimulation Frequency: 80Hz
Stimulation Duration: 6 seconds stimulation/4 seconds pause,
6 seconds exhalation/4 seconds inhalation, 30 minutes
Transcutaneous auricular vagus nerve stimulation is performed simultaneously with deep breathing. The 6-second stimulation period is synchronized with exhalation.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study targeted undergraduate and graduate students enrolled at Niigata University of Health and Welfare. Participation criteria included voluntary participation in the study and a NDC score of mild or moderate.
Key exclusion criteria
Exclusion criteria include individuals with a history of epileptic seizures, anxiety disorders, or cardiovascular disease, neurological symptoms, facial or ear injuries, implanted metal devices such as pacemakers or artificial joints, and those taking medications that affect the autonomic nervous system.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ikumi |
| Middle name | |
| Last name | Makino |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hpm26014@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ikumi |
| Middle name | |
| Last name | Makino |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hpm26014@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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, Japan
Tel
025-257-4455
rinri@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
| 2026 | Year | 07 | Month | 23 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 01 | 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 | 07 | Month | 19 | Day |
Last modified on
| 2026 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071241
