UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035080 |
|---|---|
| Receipt number | R000039978 |
| Scientific Title | To clarify the relation between NHO voice therapy and Substance P (Exploring the Relation between Glottal Closure and Plasma Substance P) |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2023/06/05 09:59:12 |
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Basic information
Public title
To clarify the relation between NHO voice
therapy and Substance P
(Exploring the Relation between Glottal Closure and Plasma Substance P)
Acronym
NHO voice therapy(Vocal / swallowing disorder training) and Substance P
Scientific Title
To clarify the relation between NHO voice
therapy and Substance P
(Exploring the Relation between Glottal Closure and Plasma Substance P)
Scientific Title:Acronym
NHO voice therapy(Vocal / swallowing disorder training) and Substance P
Region
| Japan |
Condition
Condition
Glottal incompetence, vocal fold atrophy aged
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relation between
National Hospital Organization (NHO) voice
therapy and plasma Substance P.
Basic objectives2
Others
Basic objectives -Others
safety and efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum phonation time (MPT),Comparison with Substance P before the voice therapy and after 6-months voice therapy.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. equal and more than 65years old 2.Patient complained breathy hoarseness, cough or dysphagia. 3.Agree with NHO voice therapy 4.understood the clinical research 5.Patients has no Neuropsychi-atric disorders 6.No inflammation, tum-or paralysis, polyp, glanuloma etc. on patients vocal fold. 7.vocal fold
atrohy in both side and recognized glottal incompetence 8.possible to visit hospital. 9. responsible physician in each hospital agreed with the indication of voice therapy.
Key exclusion criteria
1. Patient could not understand Japanese or
could not record training diary.
2. Patient cloud not perform voice therapy.
3. Value of the maximum phonation time was
equal and more than 15 seconds.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda, MD.PhD |
Organization
National Hospital Organization Clinical Research Center Sensory Center
Division name
Artificial organ / device development research department
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL
+81-3-3411-0111
tsunodakoichi@kankakuki.go.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda, MD.PhD |
Organization
National Hospital Organization Clinical Research Center Sensory Center
Division name
Artificial organ / device development research department
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL
+81-3-3411-0111
Homepage URL
koichi.tsunoda@kankakuki.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center (Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Japan
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
National Hospital Organization Central Research Ethics Committee
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
| 2018 | Year | 12 | Month | 13 | 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
380
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
