UMIN-CTR Clinical Trial

Basic information
Public title	Effect of daytime naps on performance in decision-making task
Acronym	Effect of daytime naps on performance in decision-making task
Scientific Title	Effect of daytime naps on performance in decision-making task
Scientific Title:Acronym	Effect of daytime naps on performance in decision-making task
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effect of daytime naps on performance in decision-making task.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Iowa gambling task (IGT) performance
Key secondary outcomes	1)Skin conductance response during IGT 2)Heart rate variability during IGT 3)Blood flow during IGT 4)Questionnaire about IGT 5)Sleep stages evaluated by polysomnography 6)Evaluation of sleep using wrist-watch type actigraphy (Fitbit Ltd.) and MotionWatch8 (CamNtech Ltd.) 7)Skin conductance response, heart rate variability and blood flow during sleep 8)Psychomotor vigilance test performance 9)Subjective sleepiness and mood

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	nap condition
Interventions/Control_2	wake (rest) 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 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)Claustrophobic 11)Pregnancy or its possibility 12)Lactation 13)Those who have a disease that may change suddenly or its history 14)Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated 15)Subjects judged by the investigator to be inappropriate
Target sample size	120

Research contact person
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

Public contact
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

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Kyocera Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyocera Corporation
Name of secondary funder(s)

IRB Contact (For public release)
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
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	2020 Year 09 Month 24 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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 16 Day
Date of IRB	2020 Year 07 Month 31 Day
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 24 Day
Last modified on	2022 Year 07 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047810