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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042494
Receipt No. R000048510
Scientific Title Validation study about improvement effects on sleep and brain fatigue by inhalation of citrus oil-inducing odorant
Date of disclosure of the study information 2021/11/23
Last modified on 2021/05/21

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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

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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