UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042065 |
|---|---|
| Receipt number | R000048006 |
| Scientific Title | The effect of waking up strategy on morning cognitive performance |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2020/10/09 14:30:41 |
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Basic information
Public title
The effect of waking up strategy on morning cognitive performance
Acronym
The effect of waking up strategy on morning cognitive performance
Scientific Title
The effect of waking up strategy on morning cognitive performance
Scientific Title:Acronym
The effect of waking up strategy on morning cognitive performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a methodology for waking up using tactile and visual stimulation on morning cognitive performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroop test
Key secondary outcomes
Brain activities during the Stroop test
Digit symbol test
Digit symbol coding
Digit cancellation test
Profile of Mood States 2
VAS ratings for subjective stress and awareness
amylase
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Awaking with visual and tactile stimulations
Interventions/Control_2
Awaking with an alarm clock
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Right-handed
A person usually falls into a sleep from 23 pm to 24 pm
A person usually wakes up from 6 am to 8 am
Key exclusion criteria
Smoker
A person with food allergy
A person with a mental disorder
A person with a sleep problem
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Tohoku University
Division name
Department of functional brain imaging
Zip code
980-8575
Address
Sendai, Seiryo machi 4-1
TEL
022-717-7988
ryuta@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of functional brain imaging
Zip code
980-8575
Address
Sendai, Seiryo machi 4-1
TEL
022-717-7988
Homepage URL
toshiki.saito@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Institute of Ageing, Development and Cancer
Institute
Department
Personal name
Funding Source
Organization
DAIKIN INDUSTRIES, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
KYOCERA corporation
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Sendai, Seiryo-machi 2-1
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 10 | Month | 20 | 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
| 2020 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048006
