UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047983 |
|---|---|
| Receipt number | R000054701 |
| Scientific Title | Effect of acupuncture and early detection on swallowing function in elderly individuals analyzed by swallowing sound using newly-developed Swallowscope |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2025/06/10 09:25:50 |
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Basic information
Public title
Effect of acupuncture and early detection on swallowing function in elderly individuals analyzed by swallowing sound using newly-developed Swallowscope
Acronym
Effect of acupuncture and early detection on swallowing function in elderly individuals analyzed by swallowing sound using newly-developed Swallowscope
Scientific Title
Effect of acupuncture and early detection on swallowing function in elderly individuals analyzed by swallowing sound using newly-developed Swallowscope
Scientific Title:Acronym
Effect of acupuncture and early detection on swallowing function in elderly individuals analyzed by swallowing sound using newly-developed Swallowscope
Region
| Japan |
Condition
Condition
elderly individuals upper 65 years old
healthy control from 18 to 64 years old
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Early Detection of decreasing swallowing function in the Elderly individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repetitive Saliva Swallowing Test
Key secondary outcomes
tongue depressor
Oral Moisture Content
swallowing sounds
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
If the RSST was less than 3 times, PIONEX ZEROs were put at acupoints ST36 and KI3 bilaterally.
Interventions/Control_2
No acupuncture intervention if RSST was 3 or more times.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. No underlying disease directly causing dysphagia
2. The food type is normal
3. Able to self salivate and swallow
4. Able to sit position
Key exclusion criteria
1. History of cerebrovascular disease, Parkinson's disease, or other central diseases
2. Dementia, history of radiation therapy to head and neck
3. Obvious dysphagia findings
4. Difficulty with acupuncture of the lower extremities
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ayuzawa |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
3058521
Address
4-12-7, Kasuga, Tsukuba, Ibaraki, Japan
TEL
028-858-9535
sayuzawa@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
3058521
Address
4-12-7, Kasuga, Tsukuba, Ibaraki, Japan
TEL
028-858-9593
Homepage URL
suishiyama@ad.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4/12/7, Kasuga, Tsukuba, Ibaraki, Japan
Tel
029-858-9593
suishiyama@ad.tsukuba-tech.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
| 2022 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/323624-factors-contributing-to-declining-swallowing-function-in-olde
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/323624-factors-contributing-to-declining-swallowing-function-in-olde
Number of participants that the trial has enrolled
51
Results
The average tongue pressure was significantly lower in the older adult group. In RSST, declining swallowing functions were observed in seven participants in the older adult group and four in the younger age group. With self-care interventions using press needles, average RSSTs significantly improved in the older adult group from 1.4 to 2.9.
Results date posted
| 2025 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study is a prospective study. Twenty-seven individuals aged 65 and over (older adult group) and 28 individuals aged 18 to 64 (younger age group) have participated at Tsukuba University of Technology, Japan. All participants had no history of central nervous system diseases such as cerebrovascular disease, Parkinson's disease, or other diseases that directly cause dysphagia, and did not have any difficulty in swallowing when eating normal food.
Participant flow
The examination was conducted in a sitting position. First, the amount of moisture in the mouth was measured using an oral moisture meter (Mucus, Life, Japan). Next, we measured tongue pressure using a tongue pressure measuring device (TPM-02E, JMS, Hiroshima, Japan).After these examinations, the GOKURI device was attached to the subject's neck, and the RSST was performed.
Adverse events
None
Outcome measures
RSST
swallowing time
tongue pressure
saliva
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | 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
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054701
