UMIN-CTR Clinical Trial

Basic information
Public title	Development of oral function training program for cognitive function of the elderly
Acronym	Development of oral and cognitive function training programs
Scientific Title	Development of oral function training program for cognitive function of the elderly
Scientific Title:Acronym	Development of oral and cognitive function training programs
Region	Japan

Condition
Condition	Oral hypofunction dementia
Classification by specialty	Geriatrics Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop training methods based on Gamification techniques to improve not only oral function but also cognitive function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in cognitive and oral function due to training after 6weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Oral and cognitive training using tablet computer
Interventions/Control_2	Oral function training using a tablet computer
Interventions/Control_3	Control training group using tablet computer (no load on cognitive / oral function)
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	60 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Men and women aged 60-80 (at the time of registration). (2) Right-handed person. (3) Those who have completed the COVID-19 vaccine twice. (4) Those who understand the purpose and content of this research and have obtained the consent to participate in the research in writing.
Key exclusion criteria	(1) Those who have a disorder of stomatognathic function or who are undergoing treatment for it. (2) Those who need to go to the dental clinic for dental treatment during the intervention period. (3) Those who are judged to interfere with training due to denture incompatibility. (4) Denture users with 3 or more consecutive defects. (5) Eihiner classification B2-C3. (6) Those who play games for one hour or more a week. (7) Adults who do not have sufficient judgment ability. (8) Persons with a history of mental illness, diabetes, cranial nerve disease, or heart disease. (9) Those taking drugs that affect cognitive function (eg, benzodiazepines, antidepressants, central nervous system drugs). (10) Those who have a score of 26 points or less in her MMSE-J (Mini Mental State Examination-Japanese), which is a screening test for dementia. (11) Those who are currently participating in other exams, or those who have participated in other exams within 2 months before the start of the exam. (12) Those who cannot participate in the pre-examination and post-examination conducted before and after the intervention period. (13) Others who are judged to be inappropriate.
Target sample size	63

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	980-8575
Address	Sendai
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 Hospital
Division name	Advanced Prosthetic Dentistry
Zip code	9808575
Address	4-1, Seiryo-machi, Aoba-ku, Sendai
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)	NTT docomo

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Dentistry
Address	4-1, Seiryo-machi, Aoba-ku, Sendai
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	2021 Year 12 Month 01 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	No longer recruiting
Date of protocol fixation	2021 Year 11 Month 16 Day
Date of IRB	2022 Year 02 Month 08 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2023 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	2021 Year 10 Month 20 Day
Last modified on	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052294