UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040900 |
|---|---|
| Receipt number | R000046700 |
| Scientific Title | Influence of far-infrared radiation mattress pad on human thermo- and sleep-wake regulations |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2023/08/29 18:13:47 |
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Basic information
Public title
Influence of far-infrared radiation mattress pad on human thermo- and sleep-wake regulations
Acronym
Influence of far-infrared radiation mattress pad on human thermo- and sleep-wake regulations
Scientific Title
Influence of far-infrared radiation mattress pad on human thermo- and sleep-wake regulations
Scientific Title:Acronym
Influence of far-infrared radiation mattress pad on human thermo- and sleep-wake regulations
Region
| Japan |
Condition
Condition
healthy human
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
thermoregulation
Basic objectives2
Others
Basic objectives -Others
sleep-wake regulation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
core body temperature, skin temperature
Key secondary outcomes
distal-proximal skin-temperature gradient, heart rate variability, sleep parameters, subjective sleepiness, mood, cold warm sensation, restlessness
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
far-infrared mattress pad (a night of sleep)
Interventions/Control_2
sham mattress pad (a night of sleep)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Those who past and under treatments of chronic diseases (cardiovascular, hepatic, endocrine, neurological, and mental disorders).
Those who with alcoholism.
Those who using sleep agents.
Those who are shiftworkers or/and traveled across time zones in six months.
Those who with other inappropriate factors for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2071
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2071
Homepage URL
kenichik@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
PMC 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
Ethical Committee of National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2712
rinri-jimu@ncnp.go.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
| 2020 | Year | 06 | Month | 25 | 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
18
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
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046700
