UMIN-CTR Clinical Trial

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