UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020965 |
|---|---|
| Receipt number | R000023939 |
| Scientific Title | The effect of aromatherapy on improving cognitive performance |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2016/02/19 17:00:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of aromatherapy on improving cognitive performance
Acronym
The effect of aromatherapy on improving cognitive performance
Scientific Title
The effect of aromatherapy on improving cognitive performance
Scientific Title:Acronym
The effect of aromatherapy on improving cognitive performance
Region
| Japan |
Condition
Condition
Cognitively normal older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the effectiveness of aromatherapy on improving cognitive performance in cognitively normal older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rey Auditory Verbal Learning Test (RAVLT) and Paced Auditory Serial Addition Test (PASAT) at baseline and 8 weeks
Key secondary outcomes
Stait-Trait Anxiety Inventory (STAI) and Apathy Scale at baseline and 8 week
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
All participants ware a diffuser necklace everyday for 8 weeks except while bathing and sleeping. They add 1-2 drops of 100% pure essential oil into the necklace everyday.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 65 to 89 years
2) Mini-Mental State Examination (MMSE) score of 24-30
3) Capacity to provide written informed consent
Key exclusion criteria
1) Current or past history of alcohol abuse/dependence
2) Current of past history of epilepsy
3) Less than 7 years of formal education
4) Current use of antidepressant or antipsychotic medications and long term use of sedative hypnotics (including anti-anxiety) medications
5) History of psychiatric or neurological disorders that could affect cognitive functions
6) Current serious concomitant diseases (including hepatic, renal, or endocrinological illnesses)
7) Current diseases resulting in olfactory dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Tabuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
tabuchi@a8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisei Wake |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
Homepage URL
taiseiwake@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 10 | 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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023939
