UMIN-ICDS Clinical Trial

Public title

Mental and Physical Effects of Restricting Electronic Device Use Before Bedtime

Acronym

Mental and Physical Effects of Restricting Electronic Device Use Before Bedtime

Scientific Title

Mental and Physical Effects of Restricting Electronic Device Use Before Bedtime

Scientific Title:Acronym

Mental and Physical Effects of Restricting Electronic Device Use Before Bedtime

Region

Japan

Condition

Healthy workers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It has been shown that using electronic devices, mainly smartphones, before bedtime can worsen sleep quality and disrupt the body's internal rhythms. Previous studies have indicated that blue light emitted from displays suppresses melatonin, known as the sleep hormone, and that the sympathetic nervous system becomes active due to information processing and physical activity caused by operating electronic devices, making it difficult to fall asleep or wake up in the morning.
The purpose of this study is to examine the effects of restricting the use of electronic devices before bedtime on sleep and psychological state.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mean median sleep time (midpoint between bedtime and waking time) measured by activity meter during control (days 1-7) and observation (days 8-14) periods.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Those who generally go to bed around midnight every night.
2) Those with no history of psychiatric disorders, sleep disorders, or circadian rhythm sleep/wake disorders.
3) Those who are at least 20 years old and less than 40 years old at the time of consent.
4) Those who live a lifestyle of working during the day (going to work in the morning and leaving at night) 4 to 6 days a week.
5)Those who use smartphones and other devices until bedtime on a daily basis.
6) Those who own a smartphone or PC and have access to the Internet.

Key exclusion criteria

1) Those who are engaged in shift work, including night shifts and night/early morning work
2)Those who have irregular arrival and departure times (students with unstable school attendance times)
3)Those who work at home (those who are full-time housewives)
4)Those who are currently undergoing treatment for a disease that interferes with their daily life
5)Those who are taking psychotropic drugs, including sleeping pills
6)Those who are unable to discontinue the consumption of alcohol or tobacco during the 14-day research period.
7) Those who plan to stay up excessively late or stay up all night during the 14-day study period.
8) Those who plan to travel during the 14-day study period.
9) Those who are deemed inappropriate by the principal investigator.

Target sample size

20

Name of lead principal investigator

1st name	Michitaka
Middle name
Last name	Yoshimura

Organization

Aichi Toho University

Division name

Department of Human Health

Zip code

465-0097

Address

3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan

TEL

0527-82-1724

Email

suimin.study@gmail.com

Name of contact person

1st name	Michitaka
Middle name
Last name	Yoshimura

Organization

Aichi Toho University

Division name

Department of Human Health

Zip code

465-0097

Address

3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan

TEL

0527-82-1724

Homepage URL

Email

suimin.study@gmail.com

Institute

Department of Human Health, Aichi Toho University

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Aichi toho university Ethics Review Committee

Address

3-11 Heiwagaoka, Meito-ku, Nagoya, Aichi, Japan

Tel

052-782-1241

Email

https://www.aichi-toho.ac.jp/information/inquiry

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

01

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

10

Month

30

Day

Date of IRB

2023

Year

11

Month

07

Day

Anticipated trial start date

2023

Year

12

Month

18

Day

Last follow-up date

2024

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Methods
Study subjects will be randomly assigned to either the group that restricts the use of electronic devices from 10 p.m. or the group that restricts the use of electronic devices from 11 p.m. Subjects will wear the activity meters until the 14th day of the study, starting from the first day when the activity meters are worn, during the first half of the 14-day period, days 1-7, they will lead a normal life, and during the latter half, days 8-14, they will restrict the use of electronic devices before bedtime.

Recruitment
Participants will be recruited through a recruiting company. Informed consent will be obtained by using the research description.

Observation items
A) Collection of sleep data using activity meters; Day 1-14
Participants will wear a small activity meter.

B) Web questionnaire
An e-mail with a URL will be sent to the participants, and they will be asked to answer a questionnaire on the Web.

1. Questionnaire on sleep, well-being, etc.; Day 1 and Day 28
Pittsburgh Sleep Quality Index; PSQI
Morningness-Eveningness Questionnaire; MEQ
Munich ChronoType Questionnaire; MCTQ
The Work Limitations Questionnaire; WLQ
Patient Health Questionnaire; PHQ9
Mental Health Checklist; K6
Ten Item Personality Inventory; TIPI-J
Satisfaction With Life Scale; SWLS
Happiness Scale
Home lighting environment; living room lighting
Sleeping environment; type of lighting and lighting conditions while sleeping

2. Questionnaire on daily sleep and mood during the study period; every morning from the 1st day to the 14th day
Sleep diary
Frequency and duration of smartphone use before bedtime
Sleep rest feeling
Sleepiness; VAS

3. Web questionnaire on daily sleep and mood during the study period; every evening on days 1-14
Mood and sleepiness during the day; VAS

Registered date

2024

Year

01

Month

18

Day

Last modified on

2024

Year

01

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060532