UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042494 |
|---|---|
| Receipt number | 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 12:20:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048510
