Visual and Auditory Breathing-swallowing Coordinated Training
September 2, 2021 updated by: National Hospital Organization Minami Kyoto Hospital
Validation of Visual and Auditory Breathing-swallowing Coordinated Training Equipment in Healthy Individuals
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kyoto
-
Joyo, Kyoto, Japan, 610-0113
- National Hospital Organization Minami Kyoto Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Visual and Auditory Breathing-swallowing Coordinated Training device
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time from signal lighting and sounding to start swallowing
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 14, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.