UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056291 |
|---|---|
| Receipt number | R000064322 |
| Scientific Title | A study of aroma control based on perceptions of aroma from falling asleep until waking |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2026/01/22 09:27:08 |
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Basic information
Public title
A study of aroma control based on perceptions of aroma from falling asleep until waking
Acronym
A study of aroma control based on perceptions of aroma from falling asleep until waking
Scientific Title
A study of aroma control based on perceptions of aroma from falling asleep until waking
Scientific Title:Acronym
A study of aroma control based on perceptions of aroma from falling asleep until waking
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of the test aroma control/test food intake on sleep restfulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep restfulness (the feeling rested after sleep)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Comparator aroma control
Interventions/Control_2
Study aroma control
Interventions/Control_3
Study food intake
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Aged between 35 and 65 years
2)Persons with any kind of sleep-related problem (difficulty falling asleep, nocturnal awakening, early morning waking, etc.)
3)Persons who do not find the aroma of the test product unpleasant
4)Persons who have more than six hours of sleep (bedtime) per day
Key exclusion criteria
1)Currently taking (regularly using) medications for any of the following or has a chronic illness or disease under treatment.
1-a)An olfactory disorder
1-b)Cognitive dysfunction
1-c)Respiratory, neurological, or psychiatric disease
1-d)Chemical sensitivity
1-e)A sleep disorder
1-f)Heart disease
1-g)Pacemaker use
2)Persons with no food allergy to starch degradation products (origin: corn), L-serine, flavorings, citric acid, sweetener (sucralose)
3)Engaged in shiftwork or keeps irregular hours (reversed sleep/wake cycle, etc.)
4)Participates in a competitive endurance sport such as distance running, swimming, or triathlon at an elite level (places high in competitions)
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Sanae |
| Middle name | |
| Last name | Hanaoka |
Organization
Daikin Industries, Ltd.
Division name
Technology and Innovation Center
Zip code
566-8585
Address
1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd. Technology and Innovation Center
TEL
06-6195-7051
sanae.hanaoka@daikin.co.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Yasumoto |
Organization
Daikin Industries, Ltd.
Division name
Technology and Innovation Center
Zip code
566-8585
Address
1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd. Technology and
TEL
06-6195-7051
Homepage URL
chiaki.yasumoto@daikin.co.jp
Sponsor or person
Institute
Daikin Industries, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daikin Industries, Ltd.
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
Daikin Industries, Ltd.
Address
1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd. Technology and Innovation Center
Tel
06-6195-7304
rinrishinsa@daikin.co.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
| 2024 | Year | 11 | Month | 28 | 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
19
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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064322
