UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045841 |
|---|---|
| Receipt number | R000052333 |
| Scientific Title | Modified super-supraglottic swallow to strengthen laryngeal closure |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2021/10/22 22:39:38 |
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Basic information
Public title
Modified swallowing to strengthen laryngeal closure
Acronym
Modified swallowing to strengthen laryngeal closure
Scientific Title
Modified super-supraglottic swallow to strengthen laryngeal closure
Scientific Title:Acronym
mSSGS
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of modified super-supraglottic swallow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between epiglottis and arytenoid
Key secondary outcomes
position and movement in the pharynx and larynx;
rate of complete laryngeal closure;
presence or absence of penetration and aspiration;
seven grade Likert scale about ease of the procedure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
super-supraglottic swallow with or without head flexion
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy subjects who gave written informed consent
Key exclusion criteria
Subjects who had a history of stroke, neuromuscular diseases, diseases in pharynx or larynx, respiratory diseases, or upper digestive tract disorders. Speech therapists.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
fhur_2019@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
Fujita Health University
Division name
Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
Homepage URL
hkagaya2@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2021 | Year | 10 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052333
