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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Dysphasia | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 38 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |