UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011488
Receipt number 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 17:35:22

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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 or person

Institute

Kyushu University

Institute

Department

Personal name



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

Value
https://center6.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