UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060047 |
|---|---|
| Receipt number | R000068657 |
| Scientific Title | Evaluation of Pharyngeal and Esophageal Pressure During Swallowing |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 18:16:35 |
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Basic information
Public title
A Study of Pressure Changes in the Throat and Esophagus During Swallowing
Acronym
Studying Pressure in the Throat and Esophagus When Swallowing
Scientific Title
Evaluation of Pharyngeal and Esophageal Pressure During Swallowing
Scientific Title:Acronym
Pharyngeal and Esophageal Pressure During Swallowing
Region
| Japan |
Condition
Condition
Healthy individuals and patients with dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of bolus volume, bolus consistency, and swallowing maneuvers on pharyngeal and esophageal pressure during the swallowing reflex in healthy individuals and patients with dysphagia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharyngeal pressure and esophageal pressure parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Swallowing maneuver
Interventions/Control_2
Food texture
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
Healthy participants: Individuals with no clinical evidence of feeding or swallowing dysfunction.
Patients with dysphagia: Hospitalized and ambulatory patients diagnosed with dysphagia.
Key exclusion criteria
Healthy participants: Abnormal findings in feeding or swallowing function on screening.
Patients with dysphagia: Severe dysphagia with inability to ingest food orally.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Aoyagi |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
470-1101
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
TEL
0562-93-2000
yyy@rc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Aoyagi |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
603-8147
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
TEL
0562-93-2000
Homepage URL
yyy@rc5.so-net.ne.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Department of Rehabilitation Medicine, School of Medicine, Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture
Tel
0562-93-2000
yyy@rc5.so-net.ne.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
| 2025 | Year | 12 | Month | 10 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068657
