UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020227 |
|---|---|
| Receipt number | R000023362 |
| Scientific Title | The relevance of Oral Stereognosis Ability and the prefrontal cortex by NIRS |
| Date of disclosure of the study information | 2016/01/06 |
| Last modified on | 2018/10/11 23:29:23 |
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Basic information
Public title
The relevance of Oral Stereognosis Ability and the prefrontal cortex by NIRS
Acronym
The study of NIRS and Oral Stereognosis Ability
Scientific Title
The relevance of Oral Stereognosis Ability and the prefrontal cortex by NIRS
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshiaki Sekita |
Organization
Tokyo Medical and Dental University
Division name
Division of Gerodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5562
t.sekita.gero@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Teranaka |
Organization
Tokyo Medical and Dental University
Division name
Division of Gerodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5560
Homepage URL
teragerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023362
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
