Breathing-Swallowing CoordinationNCT04590391
Visual and Auditory Breathing-swallowing Coordinated Training
A study testing Visual and Auditory Breathing-swallowing Coordinated Training device in people with Breathing-Swallowing Coordination and Dysphagia Rehabilitation, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing-Swallowing Coordination, Dysphagia Rehabilitation
- What is being tested?
- Visual and Auditory Breathing-swallowing Coordinated Training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 1 Dec 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with written informed consent to participate in the study
Who cannot join
- Subjects with an apparent swallowing disorder
- Subjects with clinically evident cerebrovascular diseases
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113
About this study
Official title: 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.
- Being tested
- Visual and Auditory Breathing-swallowing Coordinated Training device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual and Auditory Breathing-swallowing Coordinated Training deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Visual and Auditory Breathing-swallowing Coordinated Training device | Other | Not described Receives: Device: Visual and Auditory Breathing-swallowing Coordinated Training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from signal lighting and sounding to start swallowing
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing-Swallowing CoordinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hospital Organization Minami Kyoto Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590391
- Sponsor's protocol ID
- 2020-20
- Status last verified
- Aug 2021
- First submitted
- 9 Oct 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Visual and Auditory Breathing-swallowing Coordinated Training Equipment in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04590391
- Acronym / sponsor ID
- 2020-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Hospital Organization Minami Kyoto HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual and Auditory Breathing-swallowing Coordinated Training device | Other | Device: Visual and Auditory Breathing-swallowing Coordinated Training device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Subjects with an apparent swallowing disorder
- Subjects with clinically evident cerebrovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual and Auditory Breathing-swallowing Coordinated Training deviceThis 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. | Device | Visual and Auditory Breathing-swallowing Coordinated Training device |
Primary outcome
Time from signal lighting and sounding to start swallowing
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual and Auditory Breathing-swallowing Coordinated Training device in people with Breathing-Swallowing Coordination and Dysphagia Rehabilitation, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from signal lighting and sounding to start swallowing (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.