UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040118
Receipt number R000045743
Scientific Title Effects of sleep deprivation on the wake state instability
Date of disclosure of the study information 2020/04/09
Last modified on 2023/04/12 10:47:51

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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 or person

Institute

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

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2019 Year 12 Month 13 Day

Date of IRB

2019 Year 12 Month 13 Day

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

2023 Year 04 Month 12 Day



Link to view the page

Value
https://center6.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