UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054737 |
|---|---|
| Receipt number | R000062540 |
| Scientific Title | Research on environments that promote sleep restfulness |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/25 13:09:41 |
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Basic information
Public title
Research on environments that promote sleep restfulness
Acronym
Research on environments that promote sleep restfulness
Scientific Title
Research on environments that promote sleep restfulness
Scientific Title:Acronym
Research on environments that promote sleep restfulness
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the regulation of thermal and odor environments and environmental light 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
| Other |
Interventions/Control_1
Temperature control (fixed)
Interventions/Control_2
Temperature control (variable)
Interventions/Control_3
Temperature control (variable) and aroma control
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Aged between 40 and 65 years
2)Agrees not to consume food or beverages with a strong odor (e.g., kimchi, garlic, curry) at dinner on intervention days.
3)Agrees not to drink alcohol on intervention days.
4)Agrees not to drink caffeine-rich drinks (coffee, tea, green tea, energy drinks, etc.) between dinner and bedtime on intervention days.
5)Agrees not to use perfume, scented body cream, or other scented cosmetic products during sleep on intervention days.
6)Agrees to avoid applying basic cosmetics (emulsions, creams, etc.) to the forehead (above the eyebrows) and behind the ears on intervention days.
7)Does not find the scent of lavender unpleasant.
8)Agrees not to use electronic devices in the bedroom (electronic devices may be brought into the bedroom and used in emergencies).
9)Agrees to finish meals at least 2 hours before bedtime and finish showering at least 1 hour before bedtime.
10)Able to maintain a consistent bedtime and waking time on intervention days.
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)Engaged in shiftwork or keeps irregular hours (reversed sleep/wake cycle, etc.)
3)Prone to skin rashes (because the electrodes used for electrocardiography and simple electroencephalography are adhesive)
4)Sleeps in the same room (bedroom) as the room in which he or she spends time while awake (living room)
5)Participates in a competitive endurance sport such as distance running, swimming, or triathlon at an elite level (places high in competitions)
Target sample size
60
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.
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
Research Ethics Review Committee of Technology and Innovation Center
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 | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062540
