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Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia

Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia - Crossover trial of information therapy for dementia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026066
Enrollment
20
Registered
2017-02-09
Start date
2017-01-27
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

Patients of dementia with behavior and psychological symptoms (BPSD)

Interventions

Exposure of inaudible sounds for 4 weeks Exposure of audible sounds for 4 weeks

Sponsors

National Center of Neurology and Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who meet criteria of major neurocognitive disorders by DSM-5 2. Patients who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.

Exclusion criteria

Exclusion criteria: 1. In case they show suicide attempt, excitement and violence. 2. In case they have history of developmental disorder, bipolar disorder. 3. In case they have hearing difficulties.

Design outcomes

Primary

MeasureTime frame
Change from the baseline by the Neuropsychaitric Inventory(NPI) scores after 4-week information therapy

Secondary

MeasureTime frame
Change from the baseline by the following items 1. EEG 2. MRI 3. Medication 4. Activities of daily living (ADL) 5. Mini Mental State Examination (MMSE) Following items in relation to safety 6. Attrition rate of any cause 7. All adverse events

Countries

Japan

Contacts

Public ContactYuichi Yamashita

National Center of Neurology and Psychiatry Department of Functional Brain Research, National Institute of Neuroscience

yamay@ncnp.go.jp042-346-1718

Outcome results

None listed

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