UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045235