UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045990 |
|---|---|
| Receipt number | R000051637 |
| Scientific Title | Randomized controlled trials on the effects of inhalation essential-oils on insomnia in the elderly with dementia |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/10/23 10:44:59 |
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Basic information
Public title
Randomized controlled trials on the effects of inhalation essential-oils on insomnia in the elderly with dementia
Acronym
Randomized controlled trials on the effects of inhalation essential-oils on insomnia
Scientific Title
Randomized controlled trials on the effects of inhalation essential-oils on insomnia in the elderly with dementia
Scientific Title:Acronym
Randomized controlled trials on the effects of inhalation essential-oils on insomnia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the hypothesis that inharation of essential oils containing the aroma component of cedrol or linalool improves insomnia in the elderly with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total sleep time,3 weeks average
Key secondary outcomes
3 week average:
Sleep efficiency
Sleep onset latency
Number of awakenings
Midway awakening time
Number of times you get out of bed
Nap time
BPSD score (NPI-NH)
Long-term care burden score (NPI-NH)
Total number of times in 3 weeks: Early morning awakening count
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention: inhalation of essential oils containing linalool or cedrol components from bedtime to morning for 3 weeks.
Interventions/Control_2
control: inhalation of jojoba oil that does not contain sleep-inducing ingredients from bedtime to morning for 3 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following A-F (partially modified diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders 3rd Edition (American Society of Sleep Medicine, 2018)).
A. The person complains of one or more of the following symptoms or the caregiver observes them.
1. Difficulty falling asleep
2. Difficulty in sustaining sleep
3. Early morning awakening
4. Refuse to go to bed at the appropriate time
5. I can't sleep without a caregiver
B. The caregiver observes if one or more of the following symptoms associated with insomnia at night are complained by the person.
1. Fatigue or fatigue
2. Poor attention, concentration and memory
3. Dysfunction in social life, family life, and work life
4. I don't feel good, I'm irritated
5. Daytime sleepiness
6. Behavioral problems (eg overactivity, impulsivity, aggression)
7. Decreased motivation, energy and spontaneity
8. Prone to negligence and accidents
9. Worried about sleeping and dissatisfied
C. Complain of the above-mentioned symptoms related to sleep / wakefulness, despite the appropriate sleep opportunities and environment.
D. A and B occur at least 3 times a week.
E. A and B are allowed for 3 months or longer.
F. Sleep / wakefulness cannot be explained by other sleep disorders.
Ii. Criteria for selecting dementia:
The criteria for selecting elderly people with dementia are the degree of independence in daily life of elderly people with dementia II-IV prepared by the Ministry of Health, Labor and Welfare.
Iii. Those who can voluntarily obtain consent to participate in the research from the person in writing or verbally.
Key exclusion criteria
1. Those whose research start date falls within one month after entering the facility
2. Persons with sleep apnea syndrome
3. Hypnotics, anxiolytics, steroids, antihypertensive drugs, bronchodilators, histamine receptor blockers, interferon preparations, anti-Parkinson's disease from 2 weeks before the start date of the study period to the end date of the study period Those who have changed / added / decreased medicine. However, if insomnia symptoms have been observed even after taking these drugs for some time, they should be included in the study.
4. Those who do not have time to get out of bed all day long
5. Persons whose health condition is judged to be unstable by facility staff (research collaborators).
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Takeda |
Organization
Komazawa Women's University
Division name
Department of Nursing
Zip code
206-8511
Address
238 Sakahama, Inagi, Tokyo, Japan. 206-8511
TEL
0423507181
ai-takeda@komajo.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Takeda |
Organization
Komazawa Women's University
Division name
Department of Nursing
Zip code
206-8511
Address
238 Sakahama, Inagi, Tokyo, Japan. 206-8511
TEL
0423507181
Homepage URL
ai-takeda@komajo.ac.jp
Sponsor or person
Institute
Komazawa Women's University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kitasato University Graduate School of Nursing
IRB Contact (For public release)
Organization
Kitasato University Faculty of Nursing Research Ethics Review Board
Address
2-1-1, Kitasato, Minami, Sagamihara, Kanagawa.
Tel
0427789281
hideko-k@nrs.kitasato-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
特別養護老人ホーム
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
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
| 2021 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051637
