UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Acronym	ORACLE trial for dementia
Scientific Title	Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.
Scientific Title:Acronym	ORACLE trial for dementia
Region	Japan

Condition
Condition	dementia
Classification by specialty	Medicine in general Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of oral myofunctional training for dementia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	MMSE
Key secondary outcomes	Background (gender, age, medical history, medication), response to calling the name, CDR-J, NPI-NH, Vitality Index, Barthel Index, GDS, PHQ9, Flow-mediated vasodiation (FMD), blood pressure, pulses, grip test, holter electrocardiography, adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Interventions) Oral myofunctional training (3 min, 5 times per day) program for 6 month
Interventions/Control_2	Control) Standard care and visiting 3 min, 5 times per day for 3 month, then start oral myofunctinlal training (3 min 5 times per day ) program for 3 month
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) Dementia person 2) Person whose MMSE score less than 24
Key exclusion criteria	1) Person who is mechanically ventilated 2) Person who has serious conditions in the oral cavity 3) In case the doctor finds any difficulty for participation
Target sample size	80

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

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
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	Clinical research network Fukuoka
Address	3-1-1, maidashi, Higashiku, Fukuoka
Tel	0926437171
Email	mail@crnfukuoka.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

・医療法人白十字会　介護老人保健施設　サン　施設長　石橋経久 〒857-1165 佐世保市大和町30番地　TEL 0956-33-7771 社会福祉法人　椿ヶ丘　特別養護老人ホーム椿ヶ丘荘　理事長　石司有理子 〒851-2404 長崎県長崎市神浦丸尾町１５５３　TEL 0959-24-0130 社会福祉法人　敬天会　　牧島荘　　理事長　栗林紘子 〒851-0114　長崎県長崎市牧島町9-1 TEL 095-837-0310 ・社会福祉法人　白寿会　白寿荘　施設長　迎　正樹 〒858-0922　長崎県佐世保市鹿子前町904-1　TEL　0956-28-1181 医療法人秋桜会　介護老人保健施設　コスモスガーデン桜の里　 総括本部長　入口初則 〒851-2207 長崎県長崎市さくらの里２丁目２７－２８　TEL 095-840-1200 ・燿光リハビリテーション病院 院長　大財　茂 〒857-0022　長崎県佐世保市山手町855-1 TEL 0956-25-3210 ・社会福祉法人佐世保白寿会　介護保健施設　さざ・煌めきの里 施設長　牧山弘孝 〒857-0337　長崎県来た松浦郡佐々町八口免805-2 TEL 0956-41-1122 ・社会医療法人財団　白十字会　介護老人保健施設　長寿苑　 施設長　長田　征三、苑長　南　祐三　 〒857-1151　長崎県佐世保市日宇町2835 TEL 0956-32-3800 介護老人保健施設カリタス 〒851-2322　長崎県長崎市西出津町67-5 TEL 0959-25-1555

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 29 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	Completed
Date of protocol fixation	2014 Year 07 Month 17 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 29 Day
Last follow-up date	2015 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 29 Day
Last modified on	2021 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016935