UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039678 |
|---|---|
| Receipt number | 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 | 2022/03/05 23:43:07 |
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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
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
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Writing manuscript
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
| 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
| 2022 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045235
