UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049241 |
|---|---|
| Receipt number | R000056048 |
| Scientific Title | Evaluation of swallowing function and development a swallowing support system. |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2026/10/29 14:12:19 |
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Basic information
Public title
Development of swallowing support system.
Acronym
Development of swallowing support system.
Scientific Title
Evaluation of swallowing function and development a swallowing support system.
Scientific Title:Acronym
Evaluation of swallowing function and development a swallowing support system.
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of effectiveness of swallowing support by laryngeal elevation support system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirm that system-assisted laryngeal elevation is performed to the same degree as manual laryngeal elevation (Mendelsohn maneuver).
Key secondary outcomes
Confirm that laryngeal elevation support by the system is not affected by individual differences.
Post questionnaire: Conpare the mendelsohn maneuver and the system-assisted laryngeal elevation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Laryngeal elevation by system, (washout),Manual laryngeal elevation
Interventions/Control_2
Manual laryngeal elevation, (washout), Laryngeal elevation by system
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who are between 18 and 65 years of age at the time of obtaining consent.
The person's free and voluntary written consent has been obtained.
Persons with normal swallowing function
Key exclusion criteria
Women who are pregnant or may become pregnant.
Women who are breastfeeding.
Persons deemed inappropriate as research subjects by the principal investigator and co-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masanao |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama University Hospital
Division name
Center of the Special Needs Dentistry
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6817
pai923mx@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanao |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama University Hospital
Division name
Center of the Special Needs Dentistry
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6817
Homepage URL
gmd421001@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-7218
mae6605@adm.okayama-u.ac.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 | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
No statistically significant differences were observed in hyoid bone displacement among the system-assisted condition, manual assistance, and saliva swallowing in either males or females. The ques- tionnaire results demonstrated reduced pain and lower perceived burden during use of the system.
Results date posted
| 2026 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Following an explanation of the study, 40 healthy adults (20 men, 20 women) aged 18 to 65 years, who had no swallowing disorders and provided consent to participate, were included.
Participant flow
During the informed consent process, healthcare professionals and the system will explain the Mendelson maneuver to the subject until they fully understand and accept it. If consent cannot be obtained, the individual will not participate in this experiment.
In the experiment, both a healthcare professional and the system will perform the procedure on each subject three times. Two experimental groups will be established based on the sequence of the procedures: "manual followed by device-assisted" and "device-assisted followed by manual." The duration of laryngeal elevation is set at 5 seconds.During the experiment, X-rays are directed at the subject's larynx to capture images. Before providing assistance with laryngeal elevation, the subject's laryngeal elevation during swallowing without such assistance is also assessed. The system is set up by a healthcare professional.The subject presses a switch to initiate laryngeal elevation. X-ray irradiation is used to record the movement of the larynx. Because X-ray imaging is required, the experiment is conducted in an X-ray fluoroscopy room.
After the experiment, participants will be asked to complete a questionnaire regarding both procedures.
Adverse events
There were no adverse events.
Outcome measures
Primary endpoint:
Footage recorded during a videofluoroscopic swallowing study:Verify whether system-assisted laryngeal elevation achieves a degree of laryngeal elevation comparable to that achieved through manual laryngeal elevation. Record and compare the distance of laryngeal displacement at rest versus during laryngeal elevation.
Secondary endpoints:
Footage recorded during a videofluoroscopic swallowing study:Verify whether the system-assisted laryngeal elevation is affected by individual differences.
Post-event survey:Have the subjects compare the Mendelson maneuver, as performed by a healthcare professional, with the holding action executed by the system.
Safety evaluation items:
Post-event survey:Assess the level of pain or discomfort.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056048
