UMIN-CTR Clinical Trial

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
Email	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
Email	t.suzuki@thu.ac.jp

Sponsor
Institute	Teikyo Heisei University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054300