UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057373 |
|---|---|
| Receipt number | R000065528 |
| Scientific Title | An exploratory crossover study of essential oil-induced sleep changes in healthy adults |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/03/24 12:20:07 |
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Basic information
Public title
An exploratory crossover study of essential oil-induced sleep changes in healthy adults
Acronym
An exploratory crossover study of essential oil-induced sleep changes in healthy adults
Scientific Title
An exploratory crossover study of essential oil-induced sleep changes in healthy adults
Scientific Title:Acronym
An exploratory crossover study of essential oil-induced sleep changes in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the psychophysiological effects of essential oils on sleep.
Basic objectives2
Others
Basic objectives -Others
Compositional analysis of essential oils.
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
VAS Questionnaire of aroma
Pittsburgh sleep quality index
Analysis of volatile components
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Essential oil
Interventions/Control_2
Squalane
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Those who are generally judged as healthy
Those who can give written consent to participate voluntarily
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
12
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
815-0032
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
815-0032
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
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ouken Co., Ltd.
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
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 | 24 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | 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 | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065528
