UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059305 |
|---|---|
| Receipt number | R000067837 |
| Scientific Title | Effects of Near-Infrared Light Irradiation on the Stellate Ganglion on the Body |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 14:03:13 |
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Basic information
Public title
Effects of Near-Infrared Light Irradiation on the Stellate Ganglion on the Body
Acronym
Effects of Near-Infrared Light Irradiation on the Stellate Ganglion on the Body
Scientific Title
Effects of Near-Infrared Light Irradiation on the Stellate Ganglion on the Body
Scientific Title:Acronym
Effects of Near-Infrared Light Irradiation on the Stellate Ganglion on the Body
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of near-infrared irradiation on respiratory function and the upper body when applied to the stellate ganglion. Additionally, examine the differences between irradiation applied to one side versus both sides.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure before and after near-infrared irradiation.
Thoracic expansion difference
Respiratory function
Muscle stiffness of upper trapezius fibers
Muscle oxygen dynamics in the upper arm
Pulse wave
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Near-Infrared Therapy(both sides)
Irradiation time: 10 minutes, OUTPUT 100%
Interventions/Control_2
Near-Infrared Therapy(one side)
Irradiation time: 10 minutes, OUTPUT 100%
Interventions/Control_3
Sham
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
Key inclusion criteria
Healthy male college students without photosensitivity
Key exclusion criteria
Individuals with photosensitivity
Individuals with current or past severe orthopedic, neurological, respiratory, or cardiovascular conditions
Individuals who have submitted a request to withdraw
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | SAIDA |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
370-0033
Address
27 Nakaoruimachi, Takasaki City, Gunma Prefecture, Japan
TEL
027-352-1291
saida@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | SAIDA |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
370-0033
Address
27 Nakaoruimachi, Takasaki City, Gunma Prefecture, Japan
TEL
027-352-1291
Homepage URL
saida@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki 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
Takasaki University of Health and Welfare
Address
27 Nakaoruimachi, Takasaki City, Gunma Prefecture, Japan
Tel
027-352-1291
saida@takasaki-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
| 2025 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067837
