UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058585 |
|---|---|
| Receipt number | R000066976 |
| Scientific Title | A cross-over exploratory study to examine sleep changes caused by bedding materials |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/24 09:58:14 |
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Basic information
Public title
A cross-over exploratory study to examine sleep changes caused by bedding materials
Acronym
Research on sleep changes caused by bedding materials
Scientific Title
A cross-over exploratory study to examine sleep changes caused by bedding materials
Scientific Title:Acronym
Research on sleep changes caused by bedding materials
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the composition of bedding materials.
Basic objectives2
Others
Basic objectives -Others
Verify the effects of the rush bedding materials on humans.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
OSA Sleep Questionnaire MA version
VAS method (impressions and preferences of scents)
Changes in brain waves (alpha waves, beta waves, theta waves, delta waves) and body movement patterns during sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Rush pillow
Interventions/Control_2
Plastic pillow
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
Applicants whose native language is Japanese
Those who can refrain from wearing clothes with fabric softener, perfume, and hair styling products on the day of the examination.
Key exclusion criteria
Those who have a smoking habit
Those who have symptoms such as olfactory disorder or rhinitis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka,Nishiku-Fukuoka, Fukuoka,Japan
TEL
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka,Nishiku-Fukuoka, Fukuoka,Japan
TEL
092-802-4675
Homepage URL
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Kuniyoshi Shimizu
Funding Source
Organization
IKEHIKO CORPORATION
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
Faculty of Agriculture, Kyushu University
Address
744 Motooka,Nishiku-Fukuoka, Fukuoka,Japan
Tel
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.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
福岡県
Institutions
Institutions
九州大学大学院農学研究院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
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 | 04 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066976
