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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036953
Receipt No. 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 2019/06/04

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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
Email 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
Email a-inaguma@bc.jp.nec.com

Sponsor
Institute NEC Solution Innovators, Ltd.
Innovation Laboratories
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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