UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059697 |
|---|---|
| Receipt number | R000068282 |
| Scientific Title | Evaluation of physiological changes using essential oils on sleep quality |
| Date of disclosure of the study information | 2025/11/08 |
| Last modified on | 2025/11/09 03:52:38 |
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Basic information
Public title
Evaluation of physiological changes using essential oils on sleep quality
Acronym
Evaluation of physiological changes using essential oils on sleep quality
Scientific Title
Evaluation of physiological changes using essential oils on sleep quality
Scientific Title:Acronym
Evaluation of physiological changes using essential oils on sleep quality
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the physiological changes by essential oils on sleep quality
Basic objectives2
Others
Basic objectives -Others
This study aims to objectively observe physiological chnages by essential oils on sleep quality. We will observe and compare the sleep states of healthy adults with insomnia tendencies when they sleep in an environment where essential oils are presented versus under a control condition. For the evaluation, a portable sleep electroencephalogram and a smart-band will be used to record sleep states and autonomic nervous system activity throughout the night. By observing changes in sleep quality induced by an essential oil, this research will explore its potential as a non-pharmacological approach to sleep quality improvement.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of deep sleep (N3) among sleep stages.
Key secondary outcomes
Proportions of each sleep stage (Awake, REM, N1, N2)
LF/HF ratio during sleep
Subjective items related to sleep quality from questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Essential oil
Interventions/Control_2
Placebo oil
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Experiences fatigue, stress, or poor sleep in daily life
2) Has never used essential oils for aromatherapy in daily life
Key exclusion criteria
1) Difficulty with tests wearing of an EEG or smart-band
2) A change in the type or brand of daily products (e.g., cosmetics, shampoo, perfume) within the past month
3) Primary occupation involving night shift work
4) Diagnosed with olfactory disorders
5) A history of allergy to aroma components (or essential oil ingredients)
6) Regular use of sleep, anti-allergy, or psychotropic medications within the past month
7) Pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Division of Convergence Science / Frontier Institute of Tourism Sciences
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762652259
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Division of Convergence Science / Frontier Institute of Tourism Sciences
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762652259
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
NAIA K.K.
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
Medical Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
0762652110
rinri@adm.kanazawa-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 | 11 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068282
