UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055172 |
|---|---|
| Receipt number | R000063039 |
| Scientific Title | Exploratory study on the effects of ultra-high frequency sound on autonomic regulatory function |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/06 14:00:11 |
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Basic information
Public title
Exploratory study on the effects of ultra-high frequency sound on autonomic regulatory function
Acronym
The effects of ultra-high frequency sound on autonomic regulatory function
Scientific Title
Exploratory study on the effects of ultra-high frequency sound on autonomic regulatory function
Scientific Title:Acronym
The effects of ultra-high frequency sound on autonomic regulatory function
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of ultra-high frequency sound on autonomic regulatory function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
Skin conductivity, skin temperature, blood pressure, pulse rate, body temperature, body weight, heart rate detection task, heart rate discrimination task
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Natural environmental sounds containing frequency components above 20 kHz, the upper limit of the human audible range
Interventions/Control_2
Natural environmental sounds that do not contain frequency components above 20 kHz, the upper limit of the human audible range
Interventions/Control_3
Background noise
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who are between 18 and 70 years of age at the time of obtaining consent.
Key exclusion criteria
1) If the individual is found to lack the capacity to consent to participation in the research
2) Persons who have been diagnosed with a lifestyle-related disease (diabetes, hypertension, dyslipidemia, etc.) and are being treated with medication
3) Those with diseases related to the autonomic nervous system (including both untreated and treated patients)
4) Other persons deemed inappropriate by the principal investigator
Target sample size
30
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
Zip code
187-8551
Address
4-1-1 Ogawahigashi, 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
Zip code
187-8551
Address
4-1-1 Ogawahigashi, 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 Ogawahigashi, Kodaira, Tokyo
Tel
042-341-2711
042-341-2711
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
| 2024 | Year | 08 | Month | 06 | 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
31
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063039
