agitation in people with dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - age at least 65 years; - dementia, diagnosed by a physician; - clinical agitation in 4 weeks prior to inclusion; - written consent by the patient if capacity for consent is given or written consent by the authorized proxy if an authorized proxy exists.
Exclusion criteria
Exclusion criteria: - dermal or chondral ear defects that would prevent an acupuncture treatment; - anticoagulation with phenprocoumon, warfarine or multiple anticoagulatory treatment; - elevated risk of bleeding due to coagulatory defects (e.g. hemophilia); - clinically permanent severe agitation, indicating that an acupuncture treatment might be impossible; - known physical resistance in needle-involving situations (e.g. blood collection); - physical resistance of the person during the compliance test (ear disinfection test); - acupuncture treatment during 4 weeks prior to preliminary medical exam; - vagal nerve stimulation treatment during 4 weeks prior to preliminary medical exam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome criteria is a reduction in CMAI at post-intervention compared to baseline in the intervention group compared to the control group, using a Mann-Whitney-U-Test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome criteria is a reduction in CMAI at end of follow-up compared to baseline in the intervention group compared to the control group, using a Mann-Whitney-U-Test. | — |
Countries
Germany
Contacts
salus klinik Lindow