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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04590391
Other study ID # 2020-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date March 31, 2021

Study information

Verified date August 2021
Source National Hospital Organization Minami Kyoto Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Japan National Hospital Organization Minami Kyoto Hospital Joyo Kyoto

Sponsors (1)

Lead Sponsor Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from signal lighting and sounding to start swallowing Day 1