UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049384 |
|---|---|
| Receipt number | R000056233 |
| Scientific Title | Elucidation of swallowing dynamics in the elderly using 320-row area detector computed tomography |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/05/08 21:03:51 |
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Basic information
Public title
Elucidation of swallowing mechanisms in the elderly using computed tomography
Acronym
Elucidation of swallowing mechanisms in the elderly using computed tomography
Scientific Title
Elucidation of swallowing dynamics in the elderly using 320-row area detector computed tomography
Scientific Title:Acronym
Elucidation of swallowing dynamics in the elderly using 320-row area detector computed tomography
Region
| Japan |
Condition
Condition
adults without any swallowing dysfunction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will use 320-row area-detector computed tomography (320-ADCT) to temporally, spatially, and quantitatively evaluate swallowing dynamics in the elderly.
Basic objectives2
Others
Basic objectives -Others
We will examine whether the mechanism for regulating swallowing movements in response to volume and thickness functions in the elderly as it does in young adults, or in what ways it differs from that in young adults.
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of swallowing movements (onset and duration of movements starting at the beginning of hyoid bone movements)
Key secondary outcomes
Distance of movement of the hyoid and larynx, Transverse planar area of opening upper esophageal sphincter, Volume of pharynx and larynx, Liquid volume in transition
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following criteria will be selected.
(1) Able to understand the content and give informed consent
(2) Age 20 years or older
(3) Food intake level (Food Intake Level Scale) 8-10 (normal oral intake 3 times a day)
(4)Able to maintain a reclining sitting position of 60 degrees on a chair for at least 5 minutes
Key exclusion criteria
Those who meet any of the following criteria will be excluded.
-Those who have been diagnosed with dysphagia at any medical institution
-Those with a history of stroke, neuromuscular disease, organic disease of the pharynx, respiratory disease, or upper gastrointestinal disease
-Those who have difficulty in understanding the content or following verbal instructions due to a significant cognitive decline, etc.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center, Research Institute
Zip code
474-8511
Address
7-430 Morioka-chou, Obu, Aichi
TEL
0562-46-2311
eotaka@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Rehabilitation |
| Middle name | |
| Last name | Department of |
Organization
National Center for Geriatrics and Gerontology
Division name
Hospital
Zip code
474-8511
Address
7-430 Morioka-chou, Obu, Aichi
TEL
0562-46-2311
Homepage URL
rehab@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Rehabilitation, School of Health Sciences, Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-chou, Obu, Aichi 474-8511
Tel
0562-46-2311
yaday@ncgg.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
| 2022 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants under enrollment
Management information
Registered date
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056233
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
