UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058434 |
|---|---|
| Receipt number | R000066813 |
| Scientific Title | An Exploratory Study for the Development of Information Medicine Using Inaudible High-Frequency Sound for Diabetes Treatment |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 16:13:02 |
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Basic information
Public title
An Exploratory Study for the Development of Information Medicine Using Inaudible High-Frequency Sound for Diabetes Treatment
Acronym
Inaudible High-Frequency Sound Therapy for Diabetes
Scientific Title
An Exploratory Study for the Development of Information Medicine Using Inaudible High-Frequency Sound for Diabetes Treatment
Scientific Title:Acronym
Inaudible High-Frequency Sound Therapy for Diabetes
Region
| Japan |
Condition
Condition
Type 2 Diabetes and Prediabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop informational environmental medicine using inaudible high-frequency sound for metabolic syndrome including diabetes, we will conduct an exploratory 8-week sound exposure intervention in the daily living environments of patients currently undergoing diabetes treatment. This study aims to identify potential implementation challenges while preliminarily evaluating the effects on blood glucose monitoring as well as on diabetes- and metabolic syndrome-related indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time course of blood glucose levels will be continuously measured every 15 minutes using FreeStyle Libre before the intervention period, immediately after the start of the intervention, and just before the end of the intervention. Blood glucose fluctuations will be evaluated based on the area under the concentration-time curve (AUC) and the maximum blood concentration (Cmax); however, the calculation methods for these evaluation metrics themselves will also be a subject of investigation in this study.
Key secondary outcomes
HbA1c and fructosamine will be measured before, during, and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Acoustic information containing high-frequency components beyond the upper limit of the audible range
Interventions/Control_2
Acoustic information with only the high-frequency components removed from the same sound source
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals diagnosed with type 2 diabetes or prediabetes
2. Individuals who are currently receiving either pharmacotherapy, exercise therapy, or dietary therapy for the above condition
3. Male or female individuals aged 20 years or older and under 90 years
Key exclusion criteria
1. Individuals diagnosed with type 1 diabetes
2. Individuals for whom participation in the study is considered difficult due to dementia, psychiatric disorders, or similar conditions
3. Individuals deemed inappropriate for participation by the attending physician or principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Honda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Information Medicine, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
042-346-1718
honda@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Honda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Information Medicine, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
042-346-1718
Homepage URL
honda@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
METI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
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
| 2025 | Year | 07 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066813
