UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059356 |
|---|---|
| Receipt number | R000066468 |
| Scientific Title | Nationwide Survey of Unilateral Vocal Fold Paralysis |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 13:53:57 |
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Basic information
Public title
Nationwide Survey of Unilateral Vocal Fold Paralysis
Acronym
Nationwide Survey of Unilateral Vocal Fold Paralysis
Scientific Title
Nationwide Survey of Unilateral Vocal Fold Paralysis
Scientific Title:Acronym
Nationwide Survey of Unilateral Vocal Fold Paralysis
Region
| Japan |
Condition
Condition
Unilateral vocal fold paralysis, Recurrent nerve palsy, Laryngeal paralysis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a nationwide survey of patients with unilateral vocal cord paralysis, including age of onset, longest vocal duration, severity of hoarseness using the Voice Handicap Index (
, etc.), causative disease, duration of illness, and treatment experience.
Based on these results,
Estimate the number of patients with unilateral vocal fold paralysis in Japan
(2) Database development to create future diagnostic criteria and severity classifications for unilateral vocal fold paralysis,
3. to compare the outcomes of treatment methods for unilateral vocal fold paralysis, such as voice therapy, intravocal fold injection, and surgical treatment.
Translated with DeepL.com (free version)
Basic objectives2
Others
Basic objectives -Others
none in particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, sex, disease causing unilateral vocal fold paralysis, age of onset, duration of disease, longest vocal duration, Voice Handicap Index, etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unilateral vocal fold paralysis diagnosed as
recurrent nerve palsy (ICD-10 code G52.2),
laryngeal or vocal fold paralysis (ICD-10 code J38.0)
between January 1, 2023 and December 31, 2024
Key exclusion criteria
If the registrant is deemed unsuitable
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Watanabe |
Organization
International University of Health and Welfare
Division name
Otorhinolaryngology/Head and Neck Surgery
Zip code
107-0052
Address
8-5-35 Akasaka minatoku
TEL
0334025581
nabe@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | tomohiro |
| Middle name | |
| Last name | hasegawa |
Organization
International University of Health and Welfare
Division name
Tokyo Voice Center
Zip code
107
Address
8-5-35 Akasaka minatoku
TEL
0334025581
Homepage URL
hasetomo1982@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Junwakai Ethics Committee
Address
8-5-35 Akasaka minatoku
Tel
0334025581
hasetomo1982@gmail.com
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 | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066468
