UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051976 |
|---|---|
| Receipt number | R000059166 |
| Scientific Title | Investigation of the concentrating and relaxing effects of aroma and sound in healthy volunteers: A randomized crossover open trial |
| Date of disclosure of the study information | 2024/11/17 |
| Last modified on | 2024/02/22 16:18:42 |
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Basic information
Public title
Investigation of the concentrating and relaxing effects of aroma and sound in healthy volunteers
Acronym
Investigation of the concentrating and relaxing effects of aroma and sound
Scientific Title
Investigation of the concentrating and relaxing effects of aroma and sound in healthy volunteers: A randomized crossover open trial
Scientific Title:Acronym
Investigation of the concentrating and relaxing effects of aroma and sound: A randomized crossover open trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the concentrating and relaxing effects of aroma and sound.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean percentage change from baseline in the power of brain waves
Key secondary outcomes
･Mean percentage change from baseline in the heart rate and its variability
･Mean percentage change from baseline in the score of Visual Analog Scale (focused, calm, comfortable, fatigued, and drowsy)
･The number of correct answers and the accuracy rate of addition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects are exposed to vaporized odorless solvent (control condition)
Interventions/Control_2
Subjects are exposed to Aroma #1.
Interventions/Control_3
Subjects are exposed to Aroma #2.
Interventions/Control_4
Subjects are exposed to a certain sound.
Interventions/Control_5
Subjects are exposed to Aroma #1 and a certain sound.
Interventions/Control_6
Subjects are exposed to Aroma #2 and a certain sound.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Provided written informed consent to participate in the study.
2) Age 20-49 years (inclusive) at the timing of the consent.
3) Corrected/uncorrected visual acuity for both eyes is 0.7 or higher.
4) Able to join the study in a designated schedule and to follow study procedures.
Key exclusion criteria
1) Has been diagnosed to have smell or hearing impairments.
2) Has an ophthalmologic disease.
3) Has been diagnosed to have neurologic or psychiatric disorders.
4) Has sleep disorders.
5) Experiences symptoms due to weather sensitivity.
6) Has a history of asthmatic symptoms.
7) Female who is pregnant, lactating or planning to be pregnant during the study period.
8) Is participating in another clinical trial or planning to do so during the study period.
9) Shift-workers or night-shift workers.
10) Has a smoking habit.
11) Sees a doctor regularly or is under treatment, which the Clinical Investigator believes confounds the interpretation of the study results.
12) Dislikes a certain aroma that is used in the study.
13) The score of a specified olfactory screening test is 7 or less.
14) Has a history of hyperventilation or panic attacks in a closed space.
15) Has other conditions such as the ingestion of supplements or drugs, has allergies, or has an irregular menstrual cycle, which the Clinical Investigator believes confounds the interpretation of the study results.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Tanaka-Kanegae |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
Tanaka.Ryohei@otsuka.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Tanaka-Kanegae |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
Homepage URL
Tanaka.Ryohei@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1400
shimizu_se@otsuka.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
| 2024 | Year | 11 | Month | 17 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059166
