UMIN-CTR Clinical Trial

Public title

Effect of decision-making task on sleep

Acronym

Effect of decision-making task on sleep

Scientific Title

Effect of decision-making task on sleep

Scientific Title:Acronym

Effect of decision-making task on sleep

Region

Japan

Condition

Healthy Subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the effect of decision-making task on sleep.

Basic objectives2

Others

Basic objectives -Others

Investigating brain activity during sleep using high density EEG

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1)Amplitude of pre-REM negativity (PRN) at Fpz electrode

Key secondary outcomes

1)Brain areas estimated as the current sources of PRN
2)REM density
3)Brain potentials using high density EEG
4)Sleep stage
5)Iowa gambling task (IGT) performance
6)Skin conductance response during IGT
7)Questionnaire about IGT
8)Psychomotor vigilance test performance
9)Subjective sleepiness and mood

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Two nights' sleep in order of experimental condition, control condition

Interventions/Control_2

Two nights' sleep in order of control condition, experimental condition

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

30

years-old

>=

Gender

Male and Female

Key inclusion criteria

Participants will be included on the following all criteria.
1)Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2)Being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba.
3)Having no sleep disorder currently being treated

Key exclusion criteria

Participants will be excluded from the experiment based on the following criteria.
1)Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am, 7-9 hours of sleep)
2)BMI less than 18.5 or greater than 25
3)Worked night shifts (after 10pm) 3 months prior to the experiment
4)Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment
5)Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more)
6)Smoker
7)Consumes more than 300mg (5 cups of 150mL) of coffee every day
8)MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
9)Pittsburgh Sleep Quality Index score of greater than 5.5
10)Those who have previously conducted the decision-making task which is used in this experiment
11)Claustrophobic
12)Pregnancy or its possibility
13)Lactation
14)Those who have a disease that may change suddenly or its history
15)Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated
16)Subjects judged by the investigator to be inappropriate

Target sample size

14

Name of lead principal investigator

1st name	Takashi
Middle name
Last name	Abe

Organization

University of Tsukuba

Division name

International Institute for Integrative Sleep Medicine (WPI-IIIS)

Zip code

305-8575

Address

Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-859-1858

Email

abe.takashi.gp@u.tsukuba.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Abe

Organization

University of Tsukuba

Division name

International Institute for Integrative Sleep Medicine (WPI-IIIS)

Zip code

305-8575

Address

Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-859-1858

Homepage URL

Email

abe.takashi.gp@u.tsukuba.ac.jp

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Ethics Review Committee, University of Tsukuba Hospital

Address

Amakubo, Tsukuba, Ibaraki 305-5876, Japan

Tel

029-853-3914

Email

jisedai@md.tsukuba.ac.jp

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

2020

Year

11

Month

26

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

Preinitiation

Date of protocol fixation

2020

Year

11

Month

18

Day

Date of IRB

Anticipated trial start date

2020

Year

12

Month

09

Day

Last follow-up date

2021

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

26

Day

Last modified on

2020

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048582