UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054762 |
|---|---|
| Receipt number | R000062541 |
| Scientific Title | The effect of thickened carbonated water on swallowing function during the oral preparatory and oral transit phases. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/24 15:42:57 |
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Basic information
Public title
The effect of thickened carbonated water on swallowing function
Acronym
The effect of thickened carbonated water on swallowing function
Scientific Title
The effect of thickened carbonated water on swallowing function during the oral preparatory and oral transit phases.
Scientific Title:Acronym
The effect of thickened carbonated water on swallowing function during the oral preparatory and oral transit phases.
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effect of thickened carbonated soda water on swallowing function during the preparatory and oral phases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oral transit time
Key secondary outcomes
Modified Water Swallowing Test
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All individuals who received rehabilitative intervention by a speech-language pathologist and had a swallowing function evaluation
Key exclusion criteria
none
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nishino |
Organization
Rakuwakai Marutamachi hospital
Division name
rehabilitation department
Zip code
604-8401
Address
Marutamachi agaru, hichihonmatsu dori, Nakagyo-ku, Kyoto-shi, Kyoto
TEL
0758010351
nishino-akihiro@rakuwa.or.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Ozawa |
Organization
Rakuwakai Marutamachi hospital
Division name
otolaryngology
Zip code
604-8401
Address
Marutamachi agaru, hichihonmatsu dori, Nakagyo-ku, Kyoto-shi, Kyoto
TEL
0758010351
Homepage URL
ozawa-satomi@rakuwa.or.jp
Sponsor or person
Institute
Rakwakai Healthcare System
Institute
Department
Personal name
Nishino Akihiro
Funding Source
Organization
SODA FACTORY JAPAN Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Rakwakai Healthcare System
IRB Contact (For public release)
Organization
Rakuwakai Healthcare System
Address
Chinji-cho 2, Otowa, Yamashina district, Kyoto city, Kyoto
Tel
0755934111
kotera-katsuaki@rakuwa.or.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
洛和会丸太町病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062541
