Tokyo, July 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058435) titled 'An Exploratory Clinical Study Toward the Development of a Non-Pharmacological Treatment Using Inaudible High-Frequency Sound for Behavioral and Psychological Symptoms of Dementia (BPSD)' on July 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - National Center of Neurology and Psychiatry
Condition:
Condition - Dementia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will present natural environmental sounds rich in high-frequency components as background music in group homes where patients with behavioral and psychological symptoms of dementia (BPSD) reside. As a control condition, placebo sounds will be used, consisting of the same natural environmental sounds with the high-frequency components removed. A crossover comparative trial will be conducted to evaluate the effectiveness of the high-frequency components.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Acoustic information containing inaudible high-frequency components
Interventions/Control_2 - Acoustic information with inaudible high-frequency components removed from the same sound source
Eligibility:
Age-lower limit - 55
years-old
Gender - Male and Female
Key inclusion criteria - 1. Meets the diagnostic criteria for dementia according to the DSM-5 (regardless of etiological subtype)
2. Male or female individuals aged 55 years or older and under 100 years
3. Has a caregiver who can report on the patient's daily life
4. Has a score of 6 or higher on the BPSD assessment scale NPI-Q (a questionnaire administered to the caregiver)
Key exclusion criteria - 1. Has a diagnosis of bipolar disorder, schizophrenia, or developmental disorder
2. Does not have a legal guardian or representative who can provide consent for participation in the study
3. Deemed inappropriate for participation by the attending physician or principal investigator
Target Size - 18
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 09 Month 11 Day
Date of IRB - 2024 Year 09 Month 11 Day
Anticipated trial start date - 2024 Year 12 Month 01 Day
Last follow-up date - 2025 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066815
Disclaimer: Curated by HT Syndication.
