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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048114
Receipt No. R000054791
Scientific Title Effects of Arnold nerve stimulation and thickened carbonated water on cerebral blood flow.
Date of disclosure of the study information 2022/08/01
Last modified on 2022/06/20

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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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