UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041057 |
|---|---|
| Receipt number | R000046734 |
| Scientific Title | Examination of the Efficacy of Ice Massage with an Acid Taste to Patients with an Absent Swallowing Reflex |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/01/11 12:21:54 |
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Basic information
Public title
Examination of the Efficacy of Ice Massage with an Acid Taste to Patients with an Absent Swallowing Reflex
Acronym
Examination of the Efficacy of Ice Massage with an Acid Taste to Patients
Scientific Title
Examination of the Efficacy of Ice Massage with an Acid Taste to Patients with an Absent Swallowing Reflex
Scientific Title:Acronym
Examination of the Efficacy of Ice Massage with an Acid Taste to Patients with an Absent Swallowing Reflex
Region
| Japan |
Condition
Condition
Deglutition disorder
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are conducting this clinical study to examine the efficacy of ice massage paired with an acid taste.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The threshold value of a swallowing reflex
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
(1) An ice swab impregnated with an 8% solution of tartaric acid in sterile distilled water is created.
(2) To deglutition disorder patients whose approvals were obtained after explaining the meaning of this study, the ice massage (standard method) and the new ice massage (new method) are alternatingly done four times: morning, before noon, afternoon, and early evening. Single training time is about 2 to 3 minutes.
Study schedule: It is done on all the implementation days in a rehabilitation period. The time is about 30 minutes, equivalent to one unit of rehabilitation.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women over the age of 20 with an exhibited swallowing reflex of mild severity on a swallowing video endoscopy. Medical history and complications are not considered.
Key exclusion criteria
Cases with difficulty in communication due to dementia, impaired consciousness, etc.
Cases with past surgical treatment for the tongue, palate, or pharynx
Cases with a normal swallowing reflex
Cases with taste disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sei |
Organization
Ehime University Hospital
Division name
Otolaryngology and head and neck surgery
Zip code
7910204
Address
toon city shitsukawa 454
TEL
0899605366
hirofumisei@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sei |
Organization
Ehime University Hospital
Division name
Otolaryngology and head and neck surgery
Zip code
7910204
Address
Toon city Sitsukawa 454
TEL
0899605366
Homepage URL
hirofumisei@gmail.com
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
Toon city Sitsukawa454
Tel
089-960-5172
rinri@m.ehime-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
| 2020 | Year | 09 | Month | 01 | 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
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046734
