UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Acronym	Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Scientific Title	Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Scientific Title:Acronym	Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Region	Japan

Condition
Condition	Non specific
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of continuous olfactory stimulation with essential oil on cognitive function, olfactory function, QOL, feeling and emotion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The scales of cognitive function and olfaction at 4 weeks after intervention started
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Aromatherapy using yuzu, hinoki, lavender essential oil
Interventions/Control_2	Aromatherapy using water
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	65 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Those who are not suspected case of dementia 2.Those who are not suspected case of olfactory dysfunction 3.Those who have been obtained written consent
Key exclusion criteria	1.With diseases that interrupt carrying out this study, such as malignant tumors,cardiac insufficiency, hepatic disorder, renal disorder, endocrine disease, diabetes, nutrition disorder, alcoholic, grave pulsus irregularis,and Parkinson disease 2.Taking medicine of central nerve system 3.Those who have been affected with disease of cranial nervous system and psychiatric disorder 4.Being tend to depression 5.Visiting hospital because of decline of cognitive function 6.Taking medicine or supplement in order to improve cognitive function 7.Being Certificated of Needed Long-Term Care or Needed Support 8.Those who have been undergone an operation on nose, taking Tokishakuyakusan, Ninzinneiyoutou, or steroid hormones 9.With eye diseases such as glaucoma, grave decline of eyesight, and blepharoptosis 10.With Meniere disease 11.Being prohibited participating in this study by doctors 12.Have allergies to fragrance or cosmetics 13.Don't like scent of yuzu,hinoki, and lavender 14.Have plans of surgery or trip during intervention 15.Smoker
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Chizu Middle name Last name Kumagai
Organization	Aroma Environment Association of Japan
Division name	Chairman of The Board of Directors
Zip code	151-0051
Address	5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
TEL	03-6384-2861
Email	research@aromakankyo.or.jp

Public contact
Name of contact person	1st name Chiho Middle name Last name Muto
Organization	Aroma Environment Association of Japan
Division name	Academic Research Division
Zip code	151-0051
Address	5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
TEL	03-6384-2861
Homepage URL
Email	research@aromakankyo.or.jp

Sponsor
Institute	Aroma Environment Association of Japan
Institute
Department

Funding Source
Organization	Aroma Environment Association of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aroma Environment Association of Japan
Address	5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
Tel	03-6384-2861
Email	research@aromakankyo.or.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	2022 Year 04 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	33
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	2022 Year 01 Month 21 Day
Date of IRB	2022 Year 01 Month 21 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2022 Year 05 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 30 Day
Last modified on	2022 Year 08 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053978