Back to resultsVisual and Auditory Breathing-swallowing Coordinated Training
Primary Purpose
Breathing-Swallowing Coordination, Dysphagia Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Visual and Auditory Breathing-swallowing Coordinated Training device
Sponsored by
About this trial
This is an interventional device feasibility trial for Breathing-Swallowing Coordination
Eligibility Criteria
Inclusion Criteria:
- Subjects with written informed consent to participate in the study
Exclusion Criteria:
- Subjects with an apparent swallowing disorder
- Subjects with clinically evident cerebrovascular diseases
Sites / Locations
- National Hospital Organization Minami Kyoto Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Visual and Auditory Breathing-swallowing Coordinated Training device
Arm Description
Outcomes
Primary Outcome Measures
Time from signal lighting and sounding to start swallowing
Secondary Outcome Measures
Full Information
NCT ID
NCT04590391
First Posted
October 9, 2020
Last Updated
September 2, 2021
Sponsor
National Hospital Organization Minami Kyoto Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04590391
Brief Title
Visual and Auditory Breathing-swallowing Coordinated Training
Official Title
Validation of Visual and Auditory Breathing-swallowing Coordinated Training Equipment in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Hospital Organization Minami Kyoto Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dysphagia is caused by multiple factors, and respiratory-swallowing discoordination is considered to be one of the factors. The investigators recently developed a visual and auditory breathing-swallowing coordinated training device. In this study, investigators examined the validity of a this device for healthy subjects. The investigators will examine which respiratory phase the swallowing occurs when the swallowing is started in accordance with the signal lighting and voice of this device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing-Swallowing Coordination, Dysphagia Rehabilitation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual and Auditory Breathing-swallowing Coordinated Training device
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Visual and Auditory Breathing-swallowing Coordinated Training device
Intervention Description
This device has a structure in which a band wrapped around the chest detects the respiratory phase from changes in the lung volume, and the connected device lights a signal and sounds a sound.
Primary Outcome Measure Information:
Title
Time from signal lighting and sounding to start swallowing
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with written informed consent to participate in the study
Exclusion Criteria:
Subjects with an apparent swallowing disorder
Subjects with clinically evident cerebrovascular diseases
Facility Information:
Facility Name
National Hospital Organization Minami Kyoto Hospital
City
Joyo
State/Province
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Visual and Auditory Breathing-swallowing Coordinated Training
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