UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055306 |
|---|---|
| Receipt number | R000063189 |
| Scientific Title | Swallowing Assessment with Virtual Reality |
| Date of disclosure of the study information | 2024/08/22 |
| Last modified on | 2025/09/04 10:55:56 |
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Basic information
Public title
Swallowing Assessment with Virtual Reality
Acronym
Swallowing Test with VR
Scientific Title
Swallowing Assessment with Virtual Reality
Scientific Title:Acronym
Swallowing Assessment with VR
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to realise more accurate swallowing function assessment by using Virtual Reality to reproduce actual eating situations, thereby enhancing the ecological validity of swallowing function assessment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing endoscopy score
Key secondary outcomes
Subjective assessment of the presence of aspiration and laryngeal penetration, appetite and swallowing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
The patient is asked to wear a VR headset and a VR video is played while performing the swallowing endoscopy. The video is about one minute long and allows the patient to watch a VR video of the eating scene, providing a simulated experience of the eating scene.
Interventions/Control_2
Control group Perform routine swallowing endoscopy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following criteria for eligibility are fulfilled and not in conflict with the exclusion criteria.
Eligibility criteria.
Age 18 years or older at the time consent is obtained.
Those who have given their consent to participate in the study.
Key exclusion criteria
Those who are unable to wear a headset during swallowing assessment.
Persons who are in severe pain during the swallowing endoscopy and have difficulty in assessing normal swallowing movements.
Other persons deemed unsuitable by the principal investigator or research collaborator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kiyohito |
| Middle name | |
| Last name | Hosokawa |
Organization
Osaka university
Division name
Department of otorhinolaryngology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita city, Osaka
TEL
0668793951
hashida1223@gmail.com
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Hashida |
Organization
Osaka University hospital
Division name
Swallowing center
Zip code
5320032
Address
2-15 Yamadaoka, Suita sity, Osaka
TEL
0668793951
Homepage URL
hashida1223@gmail.com
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita sity, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2024 | Year | 08 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063189
