UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060744 |
|---|---|
| Receipt number | R000069488 |
| Scientific Title | Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG. |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/25 15:31:49 |
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Basic information
Public title
Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG.
Acronym
Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG.
Scientific Title
Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG.
Scientific Title:Acronym
Effects of down comforters blended with functional fibers on subjective sleep quality and sleep EEG.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study conducts sleep trials using down comforters among healthy male and female participants. Each participant will sleep using either a down comforter blended with functional fibers or a control down comforter blended with non-functional rayon fibers. We will record subjective sleep indices via questionnaires and perform sleep EEG measurements during the night. The objective of this study is to verify whether significant differences exist between the two types of down comforters in terms of sleep brainwaves, subjective sleep quality, and the sense of recovery upon awakening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep EEG; sleep efficiency, sleep latency
Key secondary outcomes
Sleep EEG; total sleep time, total REM sleep time, wake after sleep onset, total N1 time, total N2 time, total N3 time, percentage of REM in TST, percentage of N1 in TST, percentage of N2 in TST, percentage of N3 in TST
Pittsburg Sleep Quality Index: PSQI
OSA sleep inventory MA version
Self-deviced evaluation of sleep restfulness questionnaire
Evaluation of comforter usability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants sleep for three weeks using only a down comforter blended with functional fibers as their bedding.
Interventions/Control_2
Participants sleep for three weeks using only a down comforter blended with standard rayon fibers (without functional properties) as their bedding.
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
1. Individuals with no history of psychiatric or sleep disorders who provided informed consent to participate in the study.
2. Individuals aged 18 years or older and under 70 years at the time of obtaining consent.
3. Individuals who own a smartphone or PC and can answer questionnaire online.
Key exclusion criteria
1. Individuals currently receiving treatment for chronic respiratory, cardiac, renal, or hepatic diseases.
2. Individuals with systemic skin diseases such as severe atopic dermatitis or psoriasis.
3. Individuals receiving systemic steroids or immunosuppressants.
4. Individuals with a daily habit of alcohol consumption, smoking, or caffeine intake.
5. Individuals who are not in an environment where they can sleep alone.
6. Individuals who use far-infrared radiating materials or similar materials in their daily bedding and clothing.
7. Individuals who do not use down comorters for their regular bedding.
8. Individuals deemed unsuitable by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mayu |
| Middle name | |
| Last name | Murata |
Organization
Kawada Feather Co., Ltd.
Division name
laboratory
Zip code
515-0303
Address
3255 Yamaoyodo, Meiwa, Taki, Mie, Japan
TEL
0596-55-2431
murata@kawada.net
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Murata |
Organization
Kawada Feather Co., Ltd.
Division name
laboratory
Zip code
515-0303
Address
3255 Yamaoyodo, Meiwa, Taki, Mie, Japan
TEL
0596-55-2431
Homepage URL
murata@kawada.net
Sponsor or person
Institute
Kawada Feather Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kawada Feather Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
HASETORA SPINNING CO., LTD.
FIRBEST Co., Ltd.
Name of secondary funder(s)
HASETORA SPINNING CO., LTD.
FIRBEST Co., Ltd.
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 02 | Month | 26 | 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 | 10 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069488
