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NADA-auriculoacupuncture as a symptomatic treatment for agitation in people with dementia: a randomized, controlled, rater-blind pilot study

NADA-auriculoacupuncture as a symptomatic treatment for agitation in people with dementia: a randomized, controlled, rater-blind pilot study - NAP-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017703
Enrollment
40
Registered
2019-12-11
Start date
2017-11-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

agitation in people with dementia

Interventions

Group 1: Intervention group (IG): Participants will receive treatment as usual (TAU) of the respective nursing home (NH) plus a maximum of six treatments NADA-auriculoacupuncture (NADA-AA) within 2 w

Sponsors

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum München, LMU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactChristoph Colling

salus klinik Lindow

colling@salus-lindow.de0049-33933-880

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026