UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060192 |
|---|---|
| Receipt number | R000068848 |
| Scientific Title | Effects of Far-Infrared Blood Circulation Promotion Devices on Sleep Quality |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/18 15:14:22 |
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Basic information
Public title
Effects of Far-Infrared Blood Circulation Promotion Devices on Sleep Quality
Acronym
Effects of Far-Infrared Blood Circulation Promotion Devices on Sleep Quality
Scientific Title
Effects of Far-Infrared Blood Circulation Promotion Devices on Sleep Quality
Scientific Title:Acronym
Effects of Far-Infrared Blood Circulation Promotion Devices on Sleep Quality
Region
| Japan |
Condition
Condition
People who complaining of sleep disorders
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of bedding using far-infrared-based fibers on sleep quality and metabolism in people who complaining of sleep disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the sum of deep sleep and REM sleep
Key secondary outcomes
Differences in sleep-related items other than primary endpoint
Difference in change in Athens Insomnia Scale score
Difference in change in SPQ scores
Difference in change in nocturnal heart rate variability
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Bedding with Far-Infrared Fibers
Interventions/Control_2
Bedding without far-infrared fibers
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People who are worked at Matsushita Memorial Hospital
People from whom written informed consent to participate in the study can be obtained voluntarily
People with scoring 4 points or higher on the Athens Insomnia Scale
People aged 18 years or older but under 70 years at the time of consent acquisition
Key exclusion criteria
People who had acute infectious diseases, malignant diseases, heart disease, and other conditions requiring acute-phase treatment
Women with pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Hashimoto |
Organization
Matsushita Memorial Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
570-8540
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
TEL
0669921231
y-hashi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sugimoto |
Organization
Matsushita Memorial Hospital
Division name
Department of medical records
Zip code
570-8540
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
TEL
0669921231
Homepage URL
sugimoto.mayumi@jp.panasonic.com
Sponsor or person
Institute
Matsushita Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
TOYOSHIMA & Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsushita Memorial Hospital
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
Tel
0669921231
sugimoto.mayumi@jp.panasonic.com
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 | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 12 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068848
