UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046624 |
|---|---|
| Receipt number | R000053132 |
| Scientific Title | A fundamental study on characteristics of the sound likely to sustain attentiveness -a randomized, single blind, crossover, comparative study, for healthy adults- |
| Date of disclosure of the study information | 2023/02/12 |
| Last modified on | 2022/06/17 11:14:20 |
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Basic information
Public title
A fundamental study on characteristics of the sound likely to sustain attentiveness
-a randomized, single blind, crossover, comparative study, for healthy adults-
Acronym
A fundamental study on characteristics of the sound likely to sustain attentiveness
-a randomized, single blind, crossover, comparative study, for healthy adults-
Scientific Title
A fundamental study on characteristics of the sound likely to sustain attentiveness
-a randomized, single blind, crossover, comparative study, for healthy adults-
Scientific Title:Acronym
A fundamental study on characteristics of the sound likely to sustain attentiveness
-a randomized, single blind, crossover, comparative study, for healthy adults-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the relation between the number of times of mind-wandering during the task to concentrate on a test sound, and characteristics of the sound, by letting subjects hear two types of test sound. This study also aims to evaluate usefulness of indices such as ocular movement as objective indices of mind-wandering.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of times of subjective mind-wandering
Key secondary outcomes
Indices concerning ocular movement
Skin conductance
Heart rate and heart rate variability
Vas questionnaire to evaluate mental state
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects are instructed to listen to test sound 1 for 10 minutes.
Interventions/Control_2
Subjects are instructed to listen to test sound 2 for 10 minutes.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Japanese male, age between 20 and 49 years at the time of informed consent
2. Those who do not have impairment in the sense of hearing
3. Those who have not been contracting eye diseases, such as cataract, infection, injury, and squint for the past half year
4. Those who do not use contact lens for astigmatism nor those of hard type
5. Those who do not work rotational shifts nor at night
6. Those who can come to the designated facility on test days
Key exclusion criteria
1. Those who have any chronic disease or impairment in the liver, the bile duct, the digestive system, the respiratory system, the kidney, the urinary system, the mental and nervous system, or the blood circulatory system
2. Those who are joining or planning to join other clinical trials during this trial
3. Those whose measured values for ocular movement are not accurate due to the reasons such as astigmatism
4. Those whose measured values for skin conductance or heart rate are not accurate
5. Those who are never aware of mind-wandering during screening test
6. Those who are judged by the principal investigator as being unsuitable for this trial due to the reasons such as usage of drugs or dietary supplements, and the bedtime and awakening hours.
Target sample size
30
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
0952-52-1522
Tanaka.Ryohei@otsuka.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD 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
Suda Clinic institutional review board
Address
2-8-14 Takadanobaba, Shinjyuku, Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2023 | Year | 02 | Month | 12 | 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
| 2021 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053132
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
