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CompletedNCT04590391Updated Sep 5, 2021

Visual and Auditory Breathing-swallowing Coordinated Training

An interventional study of Visual and Auditory Breathing-swallowing Coordinated Training device in Breathing-Swallowing Coordination and Dysphagia Rehabilitation, sponsored by National Hospital Organization Minami Kyoto Hospital. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by National Hospital Organization Minami Kyoto Hospital · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breathing-Swallowing Coordination
  • Dysphagia Rehabilitation
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 10 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

National Hospital Organization Minami Kyoto Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects with written informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Subjects with an apparent swallowing disorder
  • Subjects with clinically evident cerebrovascular diseases
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Visual and Auditory Breathing-swallowing Coordinated Training device

    Device: Visual and Auditory Breathing-swallowing Coordinated Training device

Interventions

  • DeviceVisual 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.

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What researchers measure

Primary outcomes

  1. Time from signal lighting and sounding to start swallowing

    Time frame: Day 1

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Study locations

1 site
  • National Hospital Organization Minami Kyoto Hospital
    Joyo, Kyoto 610-0113, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04590391
Lead sponsor
National Hospital Organization Minami Kyoto Hospital
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Dec 1, 2020
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Sep 5, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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