UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057251 |
|---|---|
| Receipt number | R000065377 |
| Scientific Title | Exploratory research comparing before and after intervention on sleep changes in healthy people using a new house with wooden building materials for the interior compared to an old house |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2025/03/10 15:22:16 |
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Basic information
Public title
Exploratory research on sleep changes caused by wooden building materials
Acronym
Exploratory research on sleep changes caused by wooden building materials
Scientific Title
Exploratory research comparing before and after intervention on sleep changes in healthy people using a new house with wooden building materials for the interior compared to an old house
Scientific Title:Acronym
Exploratory research on sleep changes caused by a new house using wooden building materials for the interior
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effects of moving house on humans psychophysiological activities.
Basic objectives2
Others
Basic objectives -Others
Analyze the volatile components of old and new houses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG measurements (alpha, beta, theta, delta)
Sleep score
Sleep stages
OSA sleep inventory MA version
Key secondary outcomes
Analysis of volatile components
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Moving from old house to new house
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are generally judged as healthy
Those who can give written consent to participate voluntarily (those under 18 years of age must have parental consent)
Those who can refrain from using perfume or aroma products during the measurement
Key exclusion criteria
Patients diagnosed with dementia, neurological diseases or mental illness and undergoing treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Agro-environmental Sciences
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka City, Fukuoka Prefecture
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
Agro-environmental Sciences
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-802-4675
Homepage URL
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Meeting to study the health of the wooden house. coop
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Graduate School of Agriculture Ethics Committee
Address
744 Motooka, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-802-4506
norsenryaku@jimu.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065377
