UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011730 |
|---|---|
| Receipt number | R000013715 |
| Scientific Title | Research on analysis of voice and speech for diagnosis of organic articulatory disturbance |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2020/04/08 14:11:34 |
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Basic information
Public title
Research on analysis of voice and speech for diagnosis of organic articulatory disturbance
Acronym
Research on velopharyngeal function
Scientific Title
Research on analysis of voice and speech for diagnosis of organic articulatory disturbance
Scientific Title:Acronym
Research on velopharyngeal function
Region
| Japan |
Condition
Condition
cleft palate patients and normal volunteers
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
development of system to diagnose velopharyngeal movement of the cleft palate patients three-dimensionally and quantitatively
Basic objectives2
Others
Basic objectives -Others
development of diagnostic system
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of the images
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
measurement of 3D endoscope
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
| 3 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cleft palate patients and normal volunteers
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuaki |
| Middle name | |
| Last name | Mishima |
Organization
Yamaguchi University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube City, Yamaguchi, 755-8505, Japan
TEL
0836-22-2299
kmishima@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Shiraishi |
Organization
Yamaguchi University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube City, Yamaguchi, 755-8505, Japan
TEL
0836-22-2299
Homepage URL
w010ub@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
IRB
Address
Minami-kogushi 1-1-1, Ube City, Yamaguchi, 755-8505, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2013 | Year | 09 | Month | 12 | 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
| 2012 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | 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
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013715
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/03/22 | H24-58-3（20160531）研究実施計画書 立体内視鏡 (1).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
