UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027536 |
|---|---|
| Receipt number | R000030561 |
| Scientific Title | Effect of Reclining Position on Timing of Swallowing Events in Healthy Subjects |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2017/05/29 22:45:18 |
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Basic information
Public title
Effect of Reclining Position on Timing of Swallowing Events in Healthy Subjects
Acronym
Effect of Reclining Position on Timing of Swallowing Events in Healthy Subjects
Scientific Title
Effect of Reclining Position on Timing of Swallowing Events in Healthy Subjects
Scientific Title:Acronym
Effect of Reclining Position on Timing of Swallowing Events in Healthy Subjects
Region
| Japan |
Condition
Condition
healthy adult subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of reclining position on timing of swallowing events in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The timing and duration of the movement of velopharyngeal, tongue, hyoid bone, arytenoid cartilage, and UES
Key secondary outcomes
The timing of liquid bolus reaching to pharynx and UES
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
Reclining position of 30, 60, and 90 degree with bolus volume of 3 ml and 20 ml
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who received sufficent explanation of this study, understood it well, and gave written informed consent
Key exclusion criteria
1) History of stroke, neuromuscular diseases, diseases in larynx and pharynx, respiratory diseases, upper gastrointestinal diseases
2) Students beloging to the institution of the researchers of this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Saitoh |
Organization
Fujita Health University
Division name
Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
esaitoh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Inamoto |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9000
Homepage URL
inamoto@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
Address
Tel
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
| 2017 | Year | 05 | Month | 31 | 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
The oral transit time of the 3 ml bolus was significantly shortened by reclining position. The duration of laryngeal closure was prolonged significantly at 3 ml bolus swallowing with reclining position. In some cases, laryngeal closure started earlier in reclining position when swallowing 3 ml bolus. The 3 ml bolus head did not reach to hypopharynx except for one subject when reclined. At 20 ml bolus swallowing, the timing and duration of swallowing did not change regarding to the reclining position. The comparison of 3 ml and 20 ml bolus showed significant change at all swallowing events investigated.
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
