UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055371 |
|---|---|
| Receipt number | R000063282 |
| Scientific Title | Study on healing effect of the fluctuation illumination using pulse wave |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2025/03/01 11:47:32 |
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Basic information
Public title
Study on healing effect of the fluctuation illumination using pulse wave
Acronym
Study on healing effect of the fluctuation illumination using pulse wave
Scientific Title
Study on healing effect of the fluctuation illumination using pulse wave
Scientific Title:Acronym
Study on healing effect of the fluctuation illumination using pulse wave
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop the healing LED light by using the user's pulse wave.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sympathetic nerves activity(HF)
SD method
Visual Analog Scale
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
Turn on the LED in the booth to perform the Kraepelin test.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Person that informed consent was provided.
Key exclusion criteria
Taking medicine affecting the autonomic system
Subjects judged by the investigator to be ineligible for other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Nomoto |
Organization
University of Niigata Prefecture
Division name
University of Niigata Prefecture
Zip code
95008680
Address
471 Ebigase, Higashi-ku, Niigata
TEL
0252700122
nomoto@unii.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Nomoto |
Organization
University of Niigata Prefecture
Division name
Dept. of International Studies and Regional Development
Zip code
95008680
Address
471 Ebigase, Higashi-ku, Niigata
TEL
0252700122
Homepage URL
nomoto@unii.ac.jp
Sponsor or person
Institute
University of Niigata Prefecture
Institute
Department
Personal name
Funding Source
Organization
University of Niigata Prefecture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suzuka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Niigata Prefecture
Address
471 Ebigase, Higashi-ku, Niigata
Tel
0252701300
unp@unii.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
| 2024 | Year | 09 | Month | 17 | 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
| 2024 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2030 | 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
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063282
