UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055812 |
|---|---|
| Receipt number | R000063795 |
| Scientific Title | Development and evaluation of a speech-replacement device that applies lip-reading technology for patients with speech disorders |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2024/10/11 16:53:00 |
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Basic information
Public title
Development of a speech substitute device that applies lipreading techniques for patients with speech and language disorders
Acronym
Development of a substitute voice using lipreading technology
Scientific Title
Development and evaluation of a speech-replacement device that applies lip-reading technology for patients with speech disorders
Scientific Title:Acronym
Development of substitute speech using lipreading technology and examination of its usefulness
Region
| Japan |
Condition
Condition
speech-language disorder
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and examination of the usefulness of a speech substitution device that combines lip-reading technology using machine learning and synthetic speech technology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wearing comfort, convenience, frequency of use, and situations of use of the lip-reading technology-based substitute speech devices will be evaluated through interviews and questionnaires.
Key secondary outcomes
Questionnaires to assess the quality of life of patients with existing speech-language disorders (VHI-10, V-RQOL)
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
| Device,equipment |
Interventions/Control_1
Use of a speech substitute device that applies the lipreading technology developed in this research.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with speech-language disorders aged 18 years or older attending the Department of Otolaryngology at Keio University Hospital who have given consent for this study
Key exclusion criteria
Patients whom the principal investigator determines to be inappropriate as subjects of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shuta |
| Middle name | |
| Last name | Tomisato |
Organization
Keio University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
otol.group@gmail.com
Public contact
Name of contact person
| 1st name | Shuta |
| Middle name | |
| Last name | Tomisato |
Organization
Keio University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
Homepage URL
otol.group@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self-funding research
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2033 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063795
