UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051942 |
|---|---|
| Receipt number | R000057259 |
| Scientific Title | Liquidity testing in carbonated beverages and their effect on improving swallowing function in neurodegenerative diseases -Analysis by VF(Video Fluoroscopic examination of swallowing- |
| Date of disclosure of the study information | 2023/08/18 |
| Last modified on | 2025/02/17 09:25:22 |
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Basic information
Public title
Liquidity testing in carbonated beverages and their effect on improving swallowing function in neurodegenerative diseases -Analysis by VF(Video Fluoroscopic examination of swallowing-
Acronym
Liquidity testing in carbonated beverages and their effect on improving swallowing function in neurodegenerative diseases
Scientific Title
Liquidity testing in carbonated beverages and their effect on improving swallowing function in neurodegenerative diseases -Analysis by VF(Video Fluoroscopic examination of swallowing-
Scientific Title:Acronym
Liquidity testing in carbonated beverages and their effect on improving swallowing function in neurodegenerative diseases
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of carbonic acid concentration on the liquid properties of barium solutions.
Basic objectives2
Others
Basic objectives -Others
To investigate whether the use of carbonated drinking water improves swallowing function in patients with neurological intractable diseases.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VF (videofluoroscopic examination of swallowing)
Key secondary outcomes
Phase 1 (Liquidity Test)
LST (Line Spread Test)
Syringe method
Viscometer
Carbonate meter
Phase 2
DHI (Dysphagia Handicap Index)
EAT-10 (Eating Assessment Tool)
SDQ-J (Validation of the Japanese translation of the Swallowing Disturbance Questionnaire)
VAS (Resistance to Carbonated Soft Drinks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Groups that ingest 10 ml of barium solution dissolved in tap water first, followed by 10 ml of barium solution dissolved in carbonated water later.
Interventions/Control_2
The group consumed 10 ml of barium solution dissolved in carbonated water first, and later consumed 10 ml of barium solution dissolved in tap water.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease patients who have received speech-language pathology and who have been deemed to require a contrast-enhanced swallowing examination in the course of their medical care from the receipt of research permission to March 31, 2028.
Key exclusion criteria
1) Those diagnosed with dementia
2) Others deemed inappropriate by the principal investigator
3) Those who have withdrawn consent for the research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Nakayama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Rehabilitaion
Zip code
1878551
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
TEL
0423412711
stnakayama@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Nakayama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Rehabilitation
Zip code
1878551
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
TEL
0423412711
Homepage URL
stnakayama@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
Tel
0423412711
ml_rinri-jimu@ncnp.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
| 2023 | Year | 08 | Month | 18 | 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
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not started as of the end of Feblary 2025.
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057259
