UMIN-CTR Clinical Trial

Basic information
Public title	Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Acronym	Crossover trial of information therapy for dementia
Scientific Title	Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Scientific Title:Acronym	Crossover trial of 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 efficacy of information therapy using inaudible sounds for BPSD of dementia
Basic objectives2	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 6. Attrition rate of any cause 7. All adverse events

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Exposure of inaudible sounds for 4 weeks
Interventions/Control_2	Exposure of audible sounds for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	55 years-old <=
Age-upper limit	95 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. 3. In case they have hearing difficulties.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Manabu Honda
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute of Neuroscience
Zip code
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL	042-346-1718
Email	onda@ncnp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichi Yamashita
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute of Neuroscience
Zip code
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL	042-346-1718
Homepage URL
Email	yamay@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 09 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029498

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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