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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039678
Receipt No. R000045235
Scientific Title Verification of effect of oral function training task on prevention of cognitive decline in the elderly
Date of disclosure of the study information 2020/03/06
Last modified on 2020/09/01

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Basic information
Public title Effect of oral function training on preventing cognitive decline
Acronym Effect of oral function training on preventing cognitive decline
Scientific Title Verification of effect of oral function training task on prevention of cognitive decline in the elderly
Scientific Title:Acronym Verification of effect of oral function training task on prevention of cognitive decline in the elderly
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Create an oral function training program including tasks that prevent cognitive decline
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Oxyhemoglobin change in prefrontal cortex
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Conventional Oral function training
Interventions/Control_2 Oral function training including cognitive function stimulation task
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Healthy subjects who have no abnormality in stomatognathic function
(2) Men and women aged 18 and over (at the time of registration)
(3) Right-handed person
(4) A person who understands the purpose and contents of this research and obtains the written consent
Key exclusion criteria (1) Patients with abnormal oral function
(2) Adults without sufficient judgment ability
(3) Those who are currently participating in other tests or who have participated in other tests within 2 months before the start of this test
(4) Those who have a history of mental illness, diabetes, cranial nerve disease, or heart disease (heart disease).
(5) Taking drugs that affect cognitive function (eg, benzodiazepines, antidepressants, central nervous drugs)
(6) Others who are judged inappropriate
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Sasaki
Organization Tohoku University
Division name Graduate School of Dentistry
Zip code 9808575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 0227178369
Email keiichi.sasaki.e6@tohoku.ac.jp

Public contact
Name of contact person
1st name Nobuhiro
Middle name
Last name Yoda
Organization Tohoku University
Division name Hospital
Zip code 9808575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 0227178369
Homepage URL
Email nobuhiro.yoda.e2@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Dentistry
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 022-717-8244
Email den-syom@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 03 Month 06 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 Enrolling by invitation
Date of protocol fixation
2020 Year 02 Month 25 Day
Date of IRB
2020 Year 04 Month 02 Day
Anticipated trial start date
2020 Year 04 Month 09 Day
Last follow-up date
2021 Year 03 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 03 Month 03 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045235

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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