NCT04590391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

October 9, 2020

Last Update Submit

September 2, 2021

Conditions

Breathing-Swallowing CoordinationDysphagia Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Time from signal lighting and sounding to start swallowing

    Day 1

Study Arms (1)

Visual and Auditory Breathing-swallowing Coordinated Training device

OTHER
Device: Visual and Auditory Breathing-swallowing Coordinated Training device

Interventions

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.

Visual and Auditory Breathing-swallowing Coordinated Training device

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with written informed consent to participate in the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

December 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

JP(1)