UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051246 |
|---|---|
| Receipt number | R000058442 |
| Scientific Title | The Effect of Aromatherapy on the Sleep Efficiency of Institutionalized older adults |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2023/12/02 12:42:24 |
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Basic information
Public title
Does aromatherapy improve sleep (sleep efficiency) in institutionalized older adults?
Acronym
Does Aromatherapy Improve Sleep?
Scientific Title
The Effect of Aromatherapy on the Sleep Efficiency of Institutionalized older adults
Scientific Title:Acronym
Effects of Aromatherapy on Sleep Efficiency
Region
| Japan |
Condition
Condition
Any disease can be included if the subject is a resident of a facility. (Exclusion criteria exist.)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of aromatherapy using lavender on the sleep efficiency of older adults residing in an institution by using objective measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep efficiency (measured daily for the first 10 days of the intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Study participants will be exposed to 10 days of aromatherapy (aroma period), 7 days of washout, and 10 days without aromatherapy (non-aroma period). During the aromatherapy period, participants will be surrounded by the scent of lavender throughout the day.
Interventions/Control_2
Spend time as usual without aroma.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents 65 years of age or older who have been in the facility for at least one month.
Key exclusion criteria
Mini Mental State Examination-Japanese 23 points or less, taking sleeping pills, having difficulty with the smell of lavender, suspected depression, and having a history of stroke or spinal cord injury.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
4768588
Address
-172 Fukinodai, Tokai, Aichi
TEL
0526016451
kubo-yu@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
4768588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016451
Homepage URL
kubo-yu@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi
Tel
052 601 6451
tsutsui@seijoh-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
| 2023 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058442
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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