UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049447 |
|---|---|
| Receipt number | R000054300 |
| Scientific Title | Effect of smartphone dependence on prefrontal cortex function |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2022/11/07 17:42:45 |
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Basic information
Public title
Effect of smartphone dependence on prefrontal cortex function
Acronym
Effect of smartphone dependence on prefrontal cortex function
Scientific Title
Effect of smartphone dependence on prefrontal cortex function
Scientific Title:Acronym
Effect of smartphone dependence on prefrontal cortex function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of smartphone dependence on the function of the prefrontal cortex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow on the prefrontal cortex
Key secondary outcomes
Smartphone dependency and usage
Depression
Quality of sleep
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women over the age of 18.
2. It was judged to be right-handed in the H.N. dominant hand test.
3. Owns a smartphone.
4. You can go to the research site during the research period.
5. Written consent to participate in this study is obtained.
6. Have not participated in other studies within a month.
Key exclusion criteria
1. Have an underlying diseases.
2. Have a hospital visit and it is on medication.
3. Extremely short sleep (less than 5 hours a day) or long sleep (more than 10 hours a day).
4. Have a night-owl life due to work and part-time work.
5. Smoker.
6. Significant abnormalities are observed in blood pressure, blood test, urine test, etc.
7. It was donated that 400 ml of blood within 12 weeks, 200 ml of blood within 4 weeks, and blood within 2 weeks.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Suzuki |
Organization
Teikyo Heisei University
Division name
Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
t.suzuki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Suzuki |
Organization
Teikyo Heisei University
Division name
Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
Homepage URL
t.suzuki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
Tel
03-5843-3152
rec@thu.ac.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
| 2022 | Year | 11 | Month | 07 | 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
79
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
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A negative correlation was shown between smartphone use time and cerebral blood flow in the left prefrontal cortex.
Management information
Registered date
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054300
