UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032755 |
|---|---|
| Receipt number | R000037356 |
| Scientific Title | Examination of adequacy of swallowing larynx distance estimated by NESSiE automatic evaluation program - Comparison with manual measurement from videofluoroscopic examination of swallowing- |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2022/11/30 09:54:03 |
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Basic information
Public title
Examination of adequacy of swallowing larynx distance estimated by NESSiE automatic evaluation program
- Comparison with manual measurement from videofluoroscopic examination of swallowing-
Acronym
Examination of adequacy of swallowing larynx distance estimated by NESSiE automatic evaluation program
- Comparison with manual measurement from videofluoroscopic examination of swallowing-
Scientific Title
Examination of adequacy of swallowing larynx distance estimated by NESSiE automatic evaluation program
- Comparison with manual measurement from videofluoroscopic examination of swallowing-
Scientific Title:Acronym
Examination of adequacy of swallowing larynx distance estimated by NESSiE automatic evaluation program
- Comparison with manual measurement from videofluoroscopic examination of swallowing-
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether the laryngeal elevation distance during swallowing estimated by the NESSiE automatic evaluation program is appropriate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Laryngeal elevation distance
Key secondary outcomes
Laryngeal elevation time
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult male
Key exclusion criteria
1) Persons who are allergic to X-ray contrast medium (barium sulfate)
2) Persons who have judged that the research director is inappropriate for inclusion in research
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
Shinjuku-Ku
TEL
+81332027181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
Shinjuku-Ku
TEL
0332027181
Homepage URL
jufujita@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
National Center for Global Health and Medicine
Address
1-21-1, toyama, shinjuku-ku,Tokyo,Japan
Tel
0332027181
rinrijm@hosp.ncgm.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
国立国際医療研究センター（東京）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
http://jaslht23.may-pro.net/
Publication of results
Published
Result
URL related to results and publications
http://jaslht23.may-pro.net/
Number of participants that the trial has enrolled
30
Results
83 data were obtained by simultaneous measurement of NESSiE and VF. 51/83 cases of VF randomly selected from 2 ST were analyzed, and the ICC calculated from the analysis results was 0.8 or higher. NESSiE automatically analyzed the laryngeal elevation distance of 33/83 cases, and obtained an ICC of 0.72 between the analyzed results and VF.
Results date posted
| 2022 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healty adult male
Participant flow
After obtaining informed consent from the participants to participate in the study, both VF and NESSiE will be evaluated.
Adverse events
none
Outcome measures
Laryngeal elevation distance and duration during swallowing.
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cross-sectional study to measure laryngele lifting distance during swallowing in healthy subjects
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2022 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037356
