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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041057
Receipt No. 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 2020/07/10

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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
Email 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
Email hirofumisei@gmail.com

Sponsor
Institute Ehime University Hospital
Institute
Department

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 Ehime university hospital
Address Toon city Sitsukawa454
Tel 0899605366
Email hirofumisei@gmail.com

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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 01 Day
Date of IRB
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
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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