UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052380 |
|---|---|
| Receipt number | R000056305 |
| Scientific Title | Swallowing and breathing coordination in patients with swallowing disorders |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/02 19:56:49 |
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Basic information
Public title
Swallowing and breathing coordination in patients with swallowing disorders
Acronym
Swallowing and breathing coordination
Scientific Title
Swallowing and breathing coordination in patients with swallowing disorders
Scientific Title:Acronym
Swallowing and breathing coordination
Region
| Japan |
Condition
Condition
stroke
Neurology disease
Pneumology disease
Classification by specialty
| Pneumology | Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively observe respiratory and swallowing movements and examine the differences in swallowing and respiratory coordination in normal subjects and patients with swallowing disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
apnea started time before and after swallowing, apnea duration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In healthy subjects
(1) B4S is attached to the front of the subject's neck. A respiratory sensor belt that captures respiration from thoracic movements will be attached to the lower thorax.
The number and timing of swallowing and the thorax movement waveform (respiratory waveform) during the swallowing are recorded and measured. Measurements will be taken for approximately 60 seconds per administration. (2) Video recording of the measurement is performed only with the consent of the subject.
(3) After the measurement is completed, the respiratory pause time before and after swallowing and the respiratory pause duration will be measured based on the thoracic motor waveform and the timing data of swallowing. The influence of respiration during swallowing due to age and food mass will be examined.
In swallowing disorder patients
(1) B4S is attached to the front of the subject's neck. A respiratory sensor belt that captures respiration from thoracic movements will be attached to the lower thorax.
(2) Swallowing and thorax movement waveforms (respiratory waveforms) will be recorded and measured during 3 salivary swallows and up to 5 swallows (8 swallows in total including salivary swallows) using foods and amounts determined to be safe by swallow contrast or swallow endoscopy. 60 sec. rest will be taken after each swallowing. A 60-second break will be taken between each session. (2) The subjects were asked to consent to the recording of video of the measurement.
(3) After the measurement is completed, the respiratory arrest time and respiratory arrest duration before and after swallowing will be measured based on the thoracic motor waveform and the timing data of swallowing. These data will be compared with those of healthy subjects obtained in Study 1, and the respiratory control function during swallowing in patients with feeding and swallowing disorders will be examined.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects and patients with dysphagia who have given written consent of their own free will based on a thorough understanding of the study and who are at least 20 years of age at the time of consent acquisition.
Key exclusion criteria
Normal adults
Patients with complaints of dysphagia, stroke, neuromuscular disease, organic disease of the larynx and pharynx, respiratory disease, or a history of upper gastrointestinal disease
Patients with dysphagia
1. patients who are not medically stable
2. patients who are unable to perform voluntary movements due to impaired consciousness
3. patients who are unable to receive instructions
4. patients who are not taking food orally 5. other patients
Other patients who are deemed inappropriate by the principal investigator or research coordinator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Ootaka |
Organization
Fujita Health University
Division name
School of Medicine, Department of Rehabilitation1
Zip code
470-1192
Address
1-98 Dengakugakubo Toyoake-city Aichi Japan
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Inamoto |
Organization
Fujita Health University
Division name
School of Health Sciences, Faculty of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo Toyoake-city Aichi Japan
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institution review board of Fujita Health University
Address
1-98 Dengakugakubo Toyoake-city Aichi Japan
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
| 2023 | Year | 10 | Month | 03 | 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
| 2022 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056305
