UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026066
Receipt No. R000029498
Scientific Title Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Date of disclosure of the study information 2017/02/09
Last modified on 2018/06/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.