UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042209 |
|---|---|
| Receipt number | R000048183 |
| Scientific Title | Research on clinical application of digital earplugs to autism spectrum disorders and acoustically sensitive persons |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2021/04/26 09:10:20 |
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Basic information
Public title
Research on clinical application of digital earplugs to autism spectrum disorders and acoustically sensitive persons
Acronym
Research on clinical application of digital earplugs to the autism spectrum
Scientific Title
Research on clinical application of digital earplugs to autism spectrum disorders and acoustically sensitive persons
Scientific Title:Acronym
Clinical application of digital earplugs
Region
| Japan |
Condition
Condition
Autistic spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Find out if digital earplugs are effective in improving living functions in autistic spectrum disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improving the living function of autistic patients
Key secondary outcomes
Usefulness of digital earplugs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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
Children who have obtained written consent from the surrogate and consent from the subject to participate in this study,
Patients aged 18 years or older who consented to participate in this study from the subjects themselves.
Key exclusion criteria
Exclude patients that your doctor deems inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kazuya |
| Middle name | |
| Last name | ono |
Organization
St. Marianna University School of Medicin
Division name
Psychiatry
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
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 University School of Medicin
Division name
Psychiatry
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
0449778111
Homepage URL
kazuya.ono@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicin
Psychiatry
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicin
Organization
Division
Category of Funding Organization
Self funding
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 Medicin
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
Tel
0338241198
kazuya.ono@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
聖マリアンナ医科大学病因
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
