Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia.

Randomized, multicenter, open, two-arm parallel group trial of Oral myofunctional training for Clinical evidence to dementia. - ORACLE trial for dementia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014986

Enrollment

Registered

2014-08-29

Start date

2014-08-29

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

Interventions

Interventions) Oral myofunctional training (3 min, 5 times per day) program for 6 month Control) Standard care and visiting 3 min, 5 times per day for 3 month, then start oral myofunctinlal training

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Dementia person 2) Person whose MMSE score less than 24

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
MMSE	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTomomi Ide

Kyushu University Graduate School of Medical Sciences

tomomi_i@cardiol.med.kyushu-u.ac.jp092-641-1151

Outcome results

None listed

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