Pilot Study for ORAl myofunctional CLinical Evidence: dementia

Pilot Study for ORAl myofunctional CLinical Evidence: dementia - ORACLE Pilot, TSUBAKI-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011488

Enrollment

Registered

2013-08-14

Start date

2013-08-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia persons

Interventions

Oral myofunctional training program

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Degree of care burden (NIH-NH, Zarit)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTomomi Ide

FFC inc. Business Promotion Unit

info@ffc-p.jp095-801-8023

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026