UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013726 |
|---|---|
| Receipt number | R000016019 |
| Scientific Title | Monitoring of swallowing state during eating adjusted test foods and sleep in healthy elder subjects and patients with dysphagia |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2024/04/23 10:05:44 |
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Basic information
Public title
Monitoring of swallowing state during eating adjusted test foods and sleep in healthy elder subjects and patients with dysphagia
Acronym
Monitoring of swallowing during eating and sleep
Scientific Title
Monitoring of swallowing state during eating adjusted test foods and sleep in healthy elder subjects and patients with dysphagia
Scientific Title:Acronym
Monitoring of swallowing during eating and sleep
Region
| Japan |
Condition
Condition
Patients with dysphagia
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Swallowing states during eating adjusted test foods and sleep in healthy elder subjects and patients with dysphagia are monitored. Normal ranges of parameters associated with swallowing function are estimated in parallel with the assessment of swallowing function in patients with dysphagia, and risk factors of aspiration pneumonia are explored.
Basic objectives2
Others
Basic objectives -Others
Exploration of indexes differentiating patients with dysphagia from normal subjects using parameters associated with swallowing sound, laryngeal motion, and coordination between swallowing and respiration
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parameter values of swallowing function during eating adjusted test foods and sleep in patients with dysphagia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy elder subjects (>= 65 years old) and patients with dysphagia
Key exclusion criteria
Exclusion criteria for healthy subjects
- history of aspiration pneumonia
- dementia (MMSE<27)
- cerebrovascular disease or respiratory disease
- medication with dopaminergic drug(s)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Oku |
Organization
Department of Physiology, Hyogo College of Medicine
Division name
Division of Physiome
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
yoku@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Oku |
Organization
Department of Physiology, Hyogo College of Medicine
Division name
Division of Physiome
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
Homepage URL
yoku@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
FoodCare Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6154
yukiya-h@hyo-med.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
西広島リハビリテーション病院（広島）、札幌西円山病院（北海道）、高橋病院（北海道）、
わかくさ竜間リハビリテーション病院（大阪府）、洲本伊月病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fphys.2017.00676
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fphys.2017.00676
Number of participants that the trial has enrolled
752
Results
We conclude that swallows at inappropriate timing in the respiratory cycle cause breathing-swallowing discoordination, and the prolongation of swallowing latency leads to delayed timing of the swallow, and results in an increase in the SW-I pattern in patients with dysphagia.
Results date posted
| 2019 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with dysphagia and healthy volunteers.
Participant flow
We recruited volunteer subjects from Daito City Cohort, who regularly participate in community-operated exercise program for care prevention.
We also recruited 30 patients with dysphagia (stable subacute-chronic phase of illness) who were hospitalized for swallowing rehabilitation.
Adverse events
None.
Outcome measures
Breathing-swallowing pattern, timing of swallow within the respiratory cycle, pause duration for swallowing, swalloing latency
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Swallowing states during eating adjusted test foods and sleep in healthy elder subjects and patients with dysphagia are monitored using a non-invasive swallowing activity monitoring and analysis system that recognizes swallowing and assesses swallowing function by analyzing relationships among swallowing sound, laryngeal motion, and respiration.
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016019
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