UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050873 |
|---|---|
| Receipt number | R000057977 |
| Scientific Title | Effects of Interior Space Using Cedar Wood on Cognitive Function, Sleep Symptoms, and Psychological Responses of aging residents, open label, placebo controlled, cross-over trial |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/05/01 12:27:47 |
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Basic information
Public title
Effects of Interior Space Using Cedar Wood on Cognitive Function, Sleep Symptoms, and Psychological Responses of aging residents, open label, placebo controlled, cross-over trial
Acronym
Effect of cedar interior materials on aging residents
Scientific Title
Effects of Interior Space Using Cedar Wood on Cognitive Function, Sleep Symptoms, and Psychological Responses of aging residents, open label, placebo controlled, cross-over trial
Scientific Title:Acronym
Effect of cedar interior materials on aging residents
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain scientific evidence on the effects of cedar wood scent on physiological, psychological, and cerebral memory mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of normal range of total TDAS points (between 0 points and 6 points) in dementia screening secondary test.
Key secondary outcomes
Change from baseline in sleep checker good sleep rate, total point of geriatological depression rating scale, and total point of subjective well-being scale.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use cedar board panels for interior materials for 6 weeks
Interventions/Control_2
Use plastic plate panels for interior materials for 6 weeks
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) persons who is generally judged as healthy
(2) Persons who can give voluntary written consent to participate in the present trial
(3) Persons who have cognitive functions that can be subjectively evaluated
Key exclusion criteria
(1) persons who have been directed not to participate for their illness or prevention from their doctor
(2) persons with their medical histories of mental illness
(3) persons who have severe sleep disorders
(4) persons with their medical histories of brain desease
(5) persons with their medical histories of alcohol or drug dependence
(6) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(7) persons who had already participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Kyushu University Faculty of Agriculture
Division name
Department of Agro-Environmental Sciences Laboratory of Systematic Forest and Forest Products Sciences
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-802-4675
shimizu@agr.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Nagae |
Organization
Graduate School of Kyushu University Faculty of Agriculture
Division name
Department of Agro-Environmental Sciences Laboratory of Systematic Forest and Forest Products Scien
Zip code
813-0003
Address
744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-802-4946
Homepage URL
nagae.masumi.258@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Kyushu University Faculty of Agriculture
Institute
Department
Personal name
Kuniyoshi Shimizu
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
Cedar. Co., Ltd.
Pine. Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
Shiba Palace Clinic Ethics Review Committee
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
有料老人ホーム わじろの郷 （福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 01 | 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
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057977
