UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048114 |
|---|---|
| Receipt number | 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 18:26:00 |
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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
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
y.hara.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054791
