UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015301
Receipt number R000017254
Scientific Title Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Date of disclosure of the study information 2014/10/01
Last modified on 2016/04/18 13:35:37

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Basic information

Public title

Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia

Acronym

Information therapy for dementia

Scientific Title

Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia

Scientific Title:Acronym

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


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



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

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 187-8551, Japan

TEL

042-346-1718

Email

honda@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

Zip code


Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan

TEL

042-346-1718

Homepage URL


Email

yamay@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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)



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

2014 Year 10 Month 01 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

2014 Year 05 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017254


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name