UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relevance of Oral Stereognosis Ability and the prefrontal cortex by NIRS
Title of the study (Brief title)	The study of NIRS and Oral Stereognosis Ability
Region	Japan

Condition
Condition	Healthy elderly and adult
Classification by specialty	Geriatrics Rehabilitation medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of Oral Stereognosis Ability with NIRS in prefrontal cortex.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	OSA score The difference between the OxHb and DeOxy Hb be measured by NIRS (After the end of chewing motion and Kana prick out test)
Key secondary outcomes	Kana-prick out test score

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	OSA test
Interventions/Control_2	Kana-prick out test
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy elderly Healthy adult
Key exclusion criteria	Patients who do not consent to entry. History of cerebrovascular disease. Those who cannot understand the instructions of the practitioner. Who of the upper and lower jaw edentulous (denture user is acceptable). Persons with oral mucosal lesions. A person who has a neurodegenerative disease.
Target sample size	40

Research contact person
Name of lead principal investigator	Toshiaki Sekita
Organization	Tokyo Medical and Dental University
Division name	Division of Gerodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5562
Email	t.sekita.gero@tmd.ac.jp

Public contact
Name of contact person	Satoshi Teranaka
Organization	Tokyo Medical and Dental University
Division name	Division of Gerodontology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5560
Homepage URL
Email	teragerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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	東京医科歯科大学歯学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 16 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023362