UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042089