UMIN-CTR Clinical Trial

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	Institutional Review Board,Ehime University Hospital
Address	Toon city Sitsukawa454
Tel	089-960-5172
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046734