UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036953 |
|---|---|
| Receipt number | R000042089 |
| Scientific Title | the effescts of aromas on sleep, sleep + aroma, 6-day trial |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2020/06/08 17:43:28 |
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Basic information
Public title
sleep + aroma, 6-day trial
Acronym
sleep + aroma, 6-day trial
Scientific Title
the effescts of aromas on sleep, sleep + aroma, 6-day trial
Scientific Title:Acronym
the effescts of aromas on sleep, sleep + aroma, 6-day trial
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
finding aroma(s) that has good effects on sleep and awakening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
questionnaire about sleep and awakening
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
smell the aroma-A for approx. 1 min before going to bed and after getting out of bed
Interventions/Control_2
smell the aroma-B for approx. 1 min before going to bed and after getting out of bed
Interventions/Control_3
smell the aroma-C for approx. 1 min before going to bed and after getting out of bed
Interventions/Control_4
smell the aroma-D for approx. 1 min before going to bed and after getting out of bed
Interventions/Control_5
smell the aroma-E for approx. 1 min before going to bed and after getting out of bed
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
lives in Japan during the trial
Key exclusion criteria
dysosmia
takes sleeping pill everyday
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Shiratori |
Organization
NEC Solution Innovators, Ltd.
Division name
Innovation Laboratories
Zip code
277-0882
Address
5-4-19, Kashiwanoha, Kashiwa, Chiba
TEL
04-7137-1851
iku-shiratori@xc.jp.nec.com
Public contact
Name of contact person
| 1st name | Asumi |
| Middle name | |
| Last name | Inaguma |
Organization
NEC Solution Innovators, Ltd.
Division name
Innovation Laboratories
Zip code
277-0882
Address
5-4-19, Kashiwanoha, Kashiwa, Chiba
TEL
04-7137-1851
Homepage URL
a-inaguma@bc.jp.nec.com
Sponsor or person
Institute
NEC Solution Innovators, Ltd.
Innovation Laboratories
Institute
Department
Personal name
Funding Source
Organization
NEC Solution Innovators, Ltd.
Innovation Laboratories
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Kodo Co., Ltd.
REM Sleep Products Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NEC Ethical Review Committee for the Life Sciences
Address
7-1, Shiba 5-chome Minato-ku, Tokyo
Tel
03-3798-9520
rinri-shinsa@quality.jp.nec.com
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
| 2019 | Year | 06 | Month | 04 | 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
120
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
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042089
