UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057254 |
|---|---|
| Receipt number | R000065443 |
| Scientific Title | Evaluation of the Safety of Virtual Reality for Stuttering |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2026/01/11 22:45:28 |
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Basic information
Public title
Evaluation of the Safety of Virtual Reality for Stuttering
Acronym
Evaluation of the Safety of Virtual Reality for Stuttering
Scientific Title
Evaluation of the Safety of Virtual Reality for Stuttering
Scientific Title:Acronym
Evaluation of the Safety of Virtual Reality for Stuttering
Region
| Japan |
Condition
Condition
People who stutter and Typically Fluent Adults
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of virtual reality (VR) for stuttering.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Simulator Sickness Questionnaire
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Speech Training VR
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 and older
2. Patients who have provided written consent
Key exclusion criteria
1. Pregnant patients or those who may be pregnant
2. Elderly individuals aged 65 and older
3. Individuals with pre-existing binocular vision impairment
4. Individuals with mental health disorders
5. Individuals with heart disease
6. Patients deemed unsuitable for participation in this study due to severe complications or other serious conditions
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Kikuchi |
Organization
Kyushu University
Division name
Departments of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5668
kikuchi.yosikazu.544@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Kikuchi |
Organization
Kyushu University
Division name
Departments of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5668
Homepage URL
kikuchi.yosikazu.544@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan.
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
Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka Prefecture, Japan
Tel
092-642-6254
byskenkyu@jimu.kyushu-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
| 2025 | Year | 03 | 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 | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2029 | 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 | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065443
