UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Arnold nerve stimulation and thickened carbonated water on cerebral blood flow.
Acronym	Effects of Arnold nerve stimulation and thickened carbonated water on cerebral blood flow.
Scientific Title	Effects of Arnold nerve stimulation and thickened carbonated water on cerebral blood flow.
Scientific Title:Acronym	Effects of Arnold nerve stimulation and thickened carbonated water on cerebral blood flow.
Region	Japan

Condition
Condition	Dysphasia
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of changes in cerebral blood flow during cough test and Arnold's nerve acupressure in dysphagia in chronic care facilities and outpatients with dysphagia. In the same way, we will compare changes in cerebral blood flow with thickened water and carbonated thickened water.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in concentration of oxygenated hemoglobin in NIRS before and after intervention
Key secondary outcomes

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Maneuver
Interventions/Control_1	The number of intervention sessions is only one, with 2 consecutive trials each of (1) cough test and (2) Arnold's nerve acupressure. After completion of (1) and (2), the washout period in provided.
Interventions/Control_2	The number of intervention sessions is only one,with two consecutive trials each of (3) thickened water and (4) carbonated thickened water are conducted.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with dysphagia admitted to chronic care facilities and outpatients of Tokyo Medical and Dental University for swallowing rehabilitation.
Key exclusion criteria	Abnormal cardiac rhythm Heart failure Asthma
Target sample size	38

Research contact person
Name of lead principal investigator	1st name Ayako Middle name Last name Nakane
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Department of Gerodontology
Division name	Dysphagia rehabilitation
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	81-3-5803-5562
Email	a.nakane.swal@tmd.ac.jp

Public contact
Name of contact person	1st name Yoshiko Middle name Last name Hara
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Department of G
Division name	Dysphagia rehabilitation
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	81-3-5803-5562
Homepage URL
Email	y.hara.gerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University School of Dentistry Ethics Review Committee
Address	1-5-45, Yushima, Bunkyo, Tokyo , JAPAN
Tel	81-3-5803-5411
Email	d-hyoka.adm@tmd.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	芦花ホーム（東京都） 東京医科歯科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 08 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	2022 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 29 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	2022 Year 06 Month 20 Day
Last modified on	2022 Year 06 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054791

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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