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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013726
Receipt No. 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 2019/10/19

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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
Middle name
Last name Yoshitaka Oku
Organization Department of Physiology, Hyogo College of Medicine
Division name Division of Physiome
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6385
Email yoku@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Oku
Organization Department of Physiology, Hyogo College of Medicine
Division name Division of Physiome
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6385
Homepage URL
Email yoku@hyo-med.ac.jp

Sponsor
Institute Kyoto University Hospital Clinical Research Center for Medical Equipment
Institute
Department

Funding Source
Organization J Craft Co.
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
Address
Tel
Email

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
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.3389/fphys.2017.00676
Number of participants that the trial has enrolled
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
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
Date trial data considered complete
Date analysis concluded

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
2019 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016019

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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