UMIN-CTR Clinical Trial

Basic information
Public title	Effects of sleep deprivation on the wake state instability
Acronym	Effects of sleep deprivation on the wake state instability
Scientific Title	Effects of sleep deprivation on the wake state instability
Scientific Title:Acronym	Effects of sleep deprivation on the wake state instability
Region	Japan

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

Objectives
Narrative objectives1	To understand the effects of sleep deprivation on the wake state instability
Basic objectives2	Others
Basic objectives -Others	To understand the effects of sleep deprivation on the cognitive performance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Psychomotor vigilance task 2. Time production task
Key secondary outcomes	1. Wakefulness 2. Subjective sleepiness / fatigue 3. Sleep architecture during sleep and sleep deprivation

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	A. normal sleep B. sleep deprivation The order of laboratory is (A, B).
Interventions/Control_2	A. normal sleep B. sleep deprivation The order of laboratory is (B, A).
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	1. Those who do not have difficulty in filling out Japanese explanatory documents, consent forms, and survey forms 2. Those who can stay in the examination room on the 5th floor of the Innovation Medical Research Institute, University of Tsukuba 3. Those who have never been treated for mental illness or sleep disorder 4. Those who currently have no symptoms to be treated 5. Those who can visit the lab or return home by walking, public transportation, or pick-up by others Driving by themselves (including bicycles) after the experiment is not allowed.
Key exclusion criteria	. Those who are living irregular lives (Regular life: 21: 00 ~ 1: 00 going to bed, getting up from 6: 00 ~ 9: 00, sleeping 7 ~ 9 hours) 2. Thin (below BMI18.5) or obese (over BMI25) physique 3. Those who worked night shift (after 22:00) within the last 3 months 4. Those who have traveled to a country with a time difference of 3 hours or more within the last 3 months 5. Those who drink alcohol regularly (at least 40 g of pure alcohol [approximate: 2 cans of beer] twice a week or more) 6. Those who have a smoking habit 7. Those who have a daily caffeine intake of 300 mg or more (approximate: 5 cups of 150 mL coffee) 8. Those who may fall under 1. -7. above during the experiment period 9. Extreme eveningness type or extreme morningness type (Morningness-Eveningness Questionnaire score 30 points or less or 70 points or above) 10. Those whose Pittsburgh Sleep Questionnaire scores more than 5.5 11. Those whose Epworth sleepiness scale score of 11 or higher 12. Those who have a disease that may change suddenly or have a history 13. Those who have claustrophobic 14. Those who are pregnant or may be pregnant 15. Those who are under lactation 16. Those who are judged by the investigator to be inappropriate
Target sample size	30

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	305-0821
Address	Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
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	305-0821
Address	Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL	029-859-1858
Homepage URL
Email	abe.takashi.gp@u.tsukuba.ac.jp

Sponsor
Institute	International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address	2-1-1 AmakuboTsukuba, Ibaraki 305-0005
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	筑波大学国際統合睡眠医科学研究機構 International Institute for Integrative Sleep Medicine, University of Tsukuba (WPI-IIIS)

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 09 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 11 Day
Last follow-up date	2020 Year 09 Month 30 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 04 Month 09 Day
Last modified on	2020 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045743

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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