UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Title of the study (Brief title)	Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Region	Japan

Condition
Condition	Healthy adult females
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to detect the smell sensitivity threshold volume of essential oil present in a microcapsule. This primary study aimed to determine the effects of a "relaxed aromatherapy sheet" attached to a microcapsule that contains lavender oil on sleep.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The frequency of rolling over in bed when subjects detected whiff in the relaxed aromatherapy sheets.
Key secondary outcomes	Feeling by rolling over in bed when subjects detected whiff in the relaxed aromatherapy sheets.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	a "relaxed aromatherapy sheet" attached to small or moderate amount of microcapsules that contains lavender oil.
Interventions/Control_2
Interventions/Control_3
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	18 years-old <=
Age-upper limit	30 years-old >
Gender	Female
Key inclusion criteria	Healty
Key exclusion criteria	1.Difficult smelling 2.Difficult resting supine and lateral position 3.Cognitive impairment 4.A person with a history of allergies (gelatin, lavender) 5.A feeling of unwellness (cold) 6.Disorder of sleep 7.Physically and mentally sick
Target sample size	100

Research contact person
Name of lead principal investigator	Tomoe Yokono
Organization	Niigata University
Division name	School of Health Sciences, Faculty of Medicine
Address	2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-0940
Email	tyokono@clg.niigata-u.ac.jp

Public contact
Name of contact person	Tomoe Yokono
Organization	Niigata University
Division name	School of Health Sciences, Faculty of Medicine
Address	2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-0940
Homepage URL
Email	tyokono@clg.niigata-u.ac.jp

Sponsor
Institute	School of Health Sciences, Faculty of Medicine, Niigata University
Institute
Department

Funding Source
Organization	Haatohuruatago Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	新潟大学

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 26 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 21 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028081