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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011488
Receipt No. R000013407
Scientific Title Pilot Study for ORAl myofunctional CLinical Evidence: dementia
Date of disclosure of the study information 2013/08/14
Last modified on 2020/03/11

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Basic information
Public title Pilot Study for ORAl myofunctional CLinical Evidence: dementia
Acronym ORACLE Pilot, TSUBAKI-2
Scientific Title Pilot Study for ORAl myofunctional CLinical Evidence: dementia
Scientific Title:Acronym ORACLE Pilot, TSUBAKI-2
Region
Japan

Condition
Condition Dementia persons
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To perform pilot study for creating evidence of oral myofunctional training for dementia persons in cognitive and physical conditions and care burden.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Degree of care burden (NIH-NH, Zarit)
Key secondary outcomes Blood pressure, pulse, frequency of stool, height, weight, degree of dementia (CDR), functional independence measurement (FIM), Mini-Mental State (MMSE), GDS, depressive state (PHQ9), oral examination, amount of saliva, cardiovascular and other vascular events, death by all cause

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 Oral myofunctional training program
Interventions/Control_2
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Person who lives or visits regularly in Social Welfare Corporation Tsubakigaoka, an Intensive Care Home for the Elderly.
2) Person who is over 60 years old.
3) Dementia person
4) Person from whom informed consent is obtained by him/herself or key-person within the three degree of kinship.
Key exclusion criteria 1) Person who is mechanically-entilated.
2) Person who has serious conditions in the oral cavity
3) In case the doctor finds any difficulty for participation.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Ide
Organization Kyushu University Hospital
Division name Department of Cardiovascular Medicine
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Ide
Organization FFC inc.
Division name Business Promotion Unit
Zip code 8510122
Address 1-3-12, Sakai, Nagasaki-city
TEL 095-801-8023
Homepage URL
Email info@ffc-p.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization IRB, Tsubakigaoka
Address 1553, maruo, Nagasaki
Tel 0959-24-0130
Email tubaki-i@dream.ocn.ne.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 社会福祉法人椿ヶ丘特別養護老人ホーム椿ヶ丘荘

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 14 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
2013 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 14 Day
Last follow-up date
2013 Year 12 Month 08 Day
Date of closure to data entry
2014 Year 06 Month 17 Day
Date trial data considered complete
2014 Year 06 Month 17 Day
Date analysis concluded
2014 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 14 Day
Last modified on
2020 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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