UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050657 |
|---|---|
| Receipt number | R000057720 |
| Scientific Title | A study on differences in the usefulness of digital earplugs for people with autism spectrum disorder and hyperacusis according to the severity of autism |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/08/31 09:46:23 |
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Basic information
Public title
A study on differences in the usefulness of digital earplugs for people with autism spectrum disorder and hyperacusis according to the severity of autism
Acronym
A study on differences in the usefulness of digital earplugs for people with autism spectrum disorder and hyperacusis according to the severity of autism
Scientific Title
A study on differences in the usefulness of digital earplugs for people with autism spectrum disorder and hyperacusis according to the severity of autism
Scientific Title:Acronym
A study on differences in the usefulness of digital earplugs for people with autism spectrum disorder and hyperacusis according to the severity of autism
Region
| Japan |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will clarify the extent to which the use of digital earplugs for ASD patients with acoustic hypersensitivity leads to improvement in their living functions with what kind of characteristics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the characteristics of ASD patients and the effect of using digital earplugs
Key secondary outcomes
Types of sounds that you are not good at
Improvement of stress based on acoustic hypersensitivity
Improvement of fatigue
Improvement of ability to study and work
Improving the scope of activities
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
| Device,equipment |
Interventions/Control_1
1 month use of digital earplugs
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
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 12 to 60 years
Patients diagnosed with autism spectrum disorder according to the American Medical Association Diagnostic Criteria DSM-5
Patients diagnosed with acoustic hypersensitivity by the attending physician (hypersensitivity here refers to cases in which hypersensitivity clearly impairs daily functioning, school attendance and work)
Patients who have obtained written consent from the research subject or their legal representative
Key exclusion criteria
Exclusion criteria Patients judged inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kauzya |
| Middle name | |
| Last name | ono |
Organization
St. Marianna School of Medicine
Division name
neuropsychiatry
Zip code
216-8511
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL
0449778111
kazuya.ono@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | kauzya |
| Middle name | |
| Last name | ono |
Organization
St. Marianna School of Medicine
Division name
neuropsychiatry
Zip code
216-8511
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL
0449778111
Homepage URL
kazuya.ono@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna School of Medicine
Institute
Department
Personal name
kazuya ono
Funding Source
Organization
St. Marianna School of Medicine
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
St. Marianna University School of Medicine Bioethics Committee Clinical Trial Subcommittee
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
Tel
0449778111
k-sienbu.mail@marianna-u.ac.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
| 2023 | Year | 03 | Month | 27 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
