UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050083 |
|---|---|
| Receipt number | R000057054 |
| Scientific Title | Effects of Far Infrared Radiation Air Conditioning on Sleep Dissatisfiers |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2024/01/19 11:18:58 |
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Basic information
Public title
Effects of Far Infrared Radiation Air Conditioning on Sleep
Acronym
Sleep test
Scientific Title
Effects of Far Infrared Radiation Air Conditioning on Sleep Dissatisfiers
Scientific Title:Acronym
Sleep test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Empirical Study on Sleep Improvement by Far Infrared Radiation Air Conditioning
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep-related indicators
Key secondary outcomes
Sleep Related Questionnaire
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sleep for 4 days in an environment with a far-infrared radiation air conditioning system
Interventions/Control_2
Sleep for 4 days in an environment with air conditioning system
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal men and women
Subjects who are aware of their sleep problems.
Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate based on a thorough understanding of the purpose and content of the study, and have given their consent to participate in the study in writing.
Key exclusion criteria
-Subjects who are currently receiving treatment (including medication) for any disease.
-Subjects who have been diagnosed with sleep disorders such as insomnia or sleep apnea syndrome and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs) or are receiving treatment with CPAP or mouthpieces, etc.
-Those who regularly use foods for specified health use, functional foods, supplements, or health foods (GABA-containing foods, lactic acid bacteria drinks, theanine-containing foods, crocetin-containing foods, polyphenol-containing foods, etc. that claim to improve sleep) that may affect the research at least 3 times a week. Subjects who regularly consume GABA-containing foods, lactic acid bacteria beverages, theanine-containing foods, crocetin-containing foods, polyphenol-containing foods, etc.) three or more times a week, and who are unable to limit their intake during the study period
-Subjects suspected of having a chronic or acute serious infectious disease
-Subjects who are scheduled to be vaccinated during the study period
-Subjects who work late at night or in shift work
-Subjects who habitually drink alcohol more than 3 times a week and more than 1 sake equivalent (beer: 1 medium bottle, whiskey: 1 double, shochu: 0.6 sake)
-Subjects with extremely irregular eating habits
-Subjects with a BMI of 30 or higher
-Subjects who are currently participating in a clinical study of other drugs or health foods, and who are scheduled to participate in another clinical study within one month after the completion of the study or after consent to participate in the study.
-Subjects who are unable to stay at the designated research site for a certain period of time
-Subjects who are otherwise deemed by the Principal Investigator to be inappropriate for participation in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | seiji |
| Middle name | |
| Last name | miyamura |
Organization
MIYA JAPAN.CO.,LTD
Division name
Chairman and Representative Director
Zip code
938-0801
Address
3545 Ogio, Kurobe City, Toyama, 938-0801,Tokyo
TEL
0765-32-3233
m-miyamura@miya-japan.co.jp
Public contact
Name of contact person
| 1st name | riku |
| Middle name | |
| Last name | miyamura |
Organization
MIYA JAPAN.CO.,LTD
Division name
Marketing Department
Zip code
938-0801
Address
3545 Ogio, Kurobe City, Toyama, 938-0801,Tokyo
TEL
0765-32-3233
Homepage URL
r-miyamura@miya-japan.co.jp
Sponsor or person
Institute
MIYA JAPAN.CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
MIYA JAPAN.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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2023 | Year | 01 | Month | 19 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057054
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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