UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005892 |
|---|---|
| Receipt number | R000006958 |
| Scientific Title | Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2014/06/26 14:14:43 |
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Basic information
Public title
Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing
Acronym
Study of voice therapy planning
Scientific Title
Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing
Scientific Title:Acronym
Study of voice therapy planning
Region
| Japan |
Condition
Condition
severe voice disorders
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to customize and evaluate a treatment plan suitable for the individual patient, rather than using a standard uniform treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
High-speed imaging and aerodynamic phonatory function test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Laryngo-microsurgery
Interventions/Control_2
Drug therapy
Interventions/Control_3
Voice therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severe voice disorders
Key exclusion criteria
Patients without severe voice disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Makiyama |
Organization
Nihon University Suruagdai Hospital
Division name
Otorhinolaryngology
Zip code
Address
1-8-13 Kandasurugadai, Chiyoda, Tokyo 141-0021
TEL
03-3293-1711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Makiyama |
Organization
Nihon University Surugadai Hospital
Division name
Otorhinolaryngology
Zip code
Address
1-8-13 Kandasurugadai, Chiyoda, Tokyo
TEL
03-3293-1711
Homepage URL
makiyama.kiyoshi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Surugadai Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
駿河台日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 30 | Day |
Last modified on
| 2014 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006958
