UMIN-CTR Clinical Trial

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
Email	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
Email	jufujita@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037356