UMIN-CTR Clinical Trial

Basic information
Public title	Validation study about improvement effects on sleep and brain fatigue by inhalation of citrus oil-inducing odorant
Acronym	Validation study about improvement effects on sleep and brain fatigue by inhalation of citrus oil-inducing odorant
Scientific Title	Validation study about improvement effects on sleep and brain fatigue by inhalation of citrus oil-inducing odorant
Scientific Title:Acronym	Validation study about improvement effects on sleep and brain fatigue by inhalation of citrus oil-inducing odorant
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to confirm whether an inhalation of test odorant could reveal some kind of improvement effect on sleep and brain fatigue
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. OSA sleep inventory 2. Pittsburg sleep questionnaire
Key secondary outcomes	1. Stress Check List 30 2. Active mass 3. Flicker 4. Mental age

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Inhalation of a test odorant-containing tap-water mist (100 mL), which is emitted from an aroma-diffuser, to the volunteer at his/her normal bedtime for a week.
Interventions/Control_2	Inhalation of a deionized water-containing tap-water mist (100 mL), which is emitted from an aroma-diffuser, to the volunteer at his/her normal bedtime for a week.
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	30 years-old <=
Age-upper limit	46 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male/female volunteers ranging in age from 30 to 45, living in Tokyo and the surrounding area. (2) Volunteers with physiologically sleepless, because of feebleness (e.g., difficulty in falling asleep for not less than 30 min, in waking up perspicuously; and/or having a nocturnal awakening, a lack of sleeping time, etc.) (3) Volunteers working for not less than 4 days a week, restricting for above 3.5 hours in the daytime. (4) Volunteers who have no difficulty in refraining from using a smartphone, a mobile phone or a personal computer, since an hour before their time to go to bed. (5) Volunteers being not poor at a sweet-smelling citrus (e.g., orange and lemon). (6) Volunteers who have no difficulty in refraining from taking in some kind of alcohol/caffeine on and after 17 o'clock during this trial. (7) Volunteers who are not planning to go on a trip, and/or be a way overnight. (8) Volunteers equipped with a capacity to breath in the odorant from the diffuser, being at home. (9) Volunteers who can give informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Volunteers falling into the habit of smoking. (2) Volunteers with the condition of being over-sensitiveness to cold, even during the summer season. (3) Volunteers with nasal congestion and/or wrong judgement of fragrance. (4) Volunteers with some kind of continuous medical treatment, at the present time. (5) Volunteers who have undergone a remedy for their sleep disorder. (6) All through this trial, volunteers who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect their sleep and/or fatigue. (7) Volunteers with high blood pressure-- a maximal blood pressure of not less than 160 mmHg, a minimal blood one of not less than 100 mmHg--, and so on. (8) Volunteers who realized that the volunteers themselves must be in a state of menopausal disorder. (9) Pregnant, lactating women, or possibly pregnant ones. (10) Volunteers having present/previous medical history of serious diseases in liver, kidney, heart, lung, and/or blood. (11) Volunteers who are now under the other clinical tests with some kind of medicine/food, or participated in those within a month before this trial. (12) Volunteers sleeping together with their family and/or children (especially in pre-school children) in a bed time. (13) Others who have been determined as ineligible for participation, according to the investigator's opinions.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Ogawa & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Graduate School of Integrative and Global Majors, Tsukuba University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2021 Year 11 Month 23 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	Completed
Date of protocol fixation	2020 Year 10 Month 20 Day
Date of IRB	2020 Year 10 Month 16 Day
Anticipated trial start date	2020 Year 11 Month 23 Day
Last follow-up date	2020 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 18 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048510