UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056571 |
|---|---|
| Receipt number | R000064651 |
| Scientific Title | Subjective sleep feeling caused by using a functional fiber blend down comforter - Study using cross over design - |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2025/04/11 09:24:26 |
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Basic information
Public title
Subjective sleep feeling caused by using a functional fiber blend down comforter - Study using cross over design -
Acronym
Subjective sleep feeling caused by using a functional fiber blend down comforter - Study using cross over design -
Scientific Title
Subjective sleep feeling caused by using a functional fiber blend down comforter - Study using cross over design -
Scientific Title:Acronym
Subjective sleep feeling caused by using a functional fiber blend down comforter - Study using cross over design -
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By sleeping with a down comforter mixed with functional fibers and a down comforter mixed with rayon, which is not made of functional fibers, we will record a questionnaire that servers as a subjective sleep index. We will examine whether there are differences in the feelings of sleep satisfaction, rest, and deep sleep between the two down comforters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version
Key secondary outcomes
Pittsburg Sleep Quality Index: PSQI
Evaluation of sleep restfulness
Evaluation of fatigue
Evaluation of comforter usability
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals who volunteered to participate in the study with no history of psychiatric disorders, sleep disorders.
2. Individuals aged 18 years or older and under 60years at the time of obtaining consent.
3. Individuals who own a smartphone or PC and can answer questionnaire online.
Key exclusion criteria
1. Individuals with underlying conditions such as chronic respiratory disease, heart disease, kidney disease, or liver disease.
2. Individuals with systemic skin diseases such as severe atopic dermatitis or psoriasis.
3. Individuals receiving systemic steroids or immunosuppressants.
4. Individuals who are not in an environment where they can sleep alone.
5. Individuals who use far-infrared radiating materials or similar materials in their daily bedding and clothing.
6. Individuals who do not use down comorters for their regular bedding.
7. Individuals deemed unsuitable by the principal investigator.
Target sample size
10
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
FIRBEST Co., Ltd.
Name of secondary funder(s)
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
| 2024 | Year | 12 | Month | 27 | 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
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study, and the study design is a single-blind crossover comparative study. Participants will sleep using a down comforter made of a functional fiber blend and a down comforter made of a rayon blend, which is not a functional fiber, to examine the differences in subjective sleep sensation.
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064651
