UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Title of the study (Brief title)	Information therapy for dementia
Region	Japan

Condition
Condition	Patients of dementia with behavior and psychological symptoms (BPSD)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of information therapy using inaudible sounds for BPSD of dementia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Change from the baseline by the Neuropsychaitric Inventory(NPI) scores after 4-week information therapy
Key secondary outcomes	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 5. Attrition rate of any cause 6. All adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Exposure of inaudible sounds for 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key 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.
Key exclusion criteria	1. In case they show suicide attempt, excitement and violence. 2. In case they have history of developmental disorder, bipolar disorder or alchol/drug abuse. 3. In case they have hearing difficulties.
Target sample size	15

Research contact person
Name of lead principal investigator	Manabu Honda
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute of Neuroscience
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL	042-346-1718
Email	honda@ncnp.go.jp

Public contact
Name of contact person	Yuichi Yamashita
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL	042-346-1718
Homepage URL
Email	yamay@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Foundation for advancement of international science
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 05 Month 16 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 01 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017254