UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057619 |
|---|---|
| Receipt number | R000065834 |
| Scientific Title | An Investigation into the Enhancement of Peripheral Tissue Perfusion by Far-Infrared Electromagnetic Radiation Emitted from Textile Materials |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/24 09:19:06 |
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Basic information
Public title
An Investigation into the Enhancement of Peripheral Tissue Perfusion by Far-Infrared Electromagnetic Radiation Emitted from Textile Materials
Acronym
An Investigation into the Enhancement of Peripheral Tissue Perfusion by Far-Infrared Electromagnetic Radiation Emitted from Textile Materials
Scientific Title
An Investigation into the Enhancement of Peripheral Tissue Perfusion by Far-Infrared Electromagnetic Radiation Emitted from Textile Materials
Scientific Title:Acronym
An Investigation into the Enhancement of Peripheral Tissue Perfusion by Far-Infrared Electromagnetic Radiation Emitted from Textile Materials
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the medical-grade mattress, Golden Value e-Ion, in accordance with the methodology outlined in the 'Voluntary Standards for Far-Infrared Ray Products for the Promotion of Blood Circulation for Home Use' established by the Japan Association for the Advancement of Medical Equipment.
Basic objectives2
Others
Basic objectives -Others
Evaluation of device performance
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The study will estimate the changes from baseline, as well as the mean values and standard deviations for each of the following parameters during the use of the Golden Value e-Ion product and a control (blank) product. Statistical comparisons will be made to assess differences between the two conditions:
I. Peripheral tissue blood flow
II. Cardiac output
Key secondary outcomes
This study will estimate the changes from baseline and compare the mean values and standard deviations for the following parameters under two conditions: use of the Golden Value e-Ion product and use of a control (blank) product. Statistical analysis will be conducted to examine differences between the two products:
I. Autonomic nervous function, as assessed by heart rate variability (HRV) analysis
II. Core body temperature
III. Blood pressure and heart rate
IV. Scores from the State-Trait Anxiety Inventory (STAI) Form Y-1 and a Visual Analog Scale (VAS) questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
During the use of the Golden Value e-Ion product for 2 hours
Interventions/Control_2
During the use of a control (blank) product for 2 hours
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 years or older at the time of consent, regardless of gender
2. Individuals who have provided written informed consent to participate in this study
Key exclusion criteria
1.Individuals with cognitive impairment, consciousness disorders, or other conditions that make self-determination difficult
2.Pregnant women or women who may be pregnant
3.Individuals with serious underlying medical conditions such as cardiovascular or respiratory diseases
4.Individuals with internal medical conditions such as hypertension or diabetes that cannot be adequately controlled with medication
5.Any other individuals deemed inappropriate for participation in the study by the investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Muramatsu |
Organization
Saitama Medical University Hospital
Division name
Preventive Medicine Center
Zip code
350-0495
Address
38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1550
toshi_m@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Katoh |
Organization
Saitama Medical University
Division name
Research Administration Center
Zip code
350-0495
Address
38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1226
Homepage URL
m_katou@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
AP RAW MATERIALS ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Ethical Review Committee, Saitama Medical University
Address
38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-2143
rinri@saitama-med.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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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 | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065834
