Trunk Inclination on Respiratory-swallowing Coordination

January 23, 2022 updated by: Chang Gung Memorial Hospital

Trunk Inclination Angle on Swallowing/Respiratory Function and the Development of Smart Positioning-angle Adjustment Device

Most caregivers do not know the influence of improper positioning therefore subjects suffer from possible choking risks. The aims of this study were to investigate the timing and coordination of swallowing and respiration in 4 different seat inclination angles, with liquid and bolus. A self-developed wearable device to measure the submandibular muscle surface EMG, the movement of thyroid cartilage and respiratory status of nasal cavity. This program could auto-analysis the onset and offset of duration, and the excursion and strength of thyroid cartilage will be calculated when it was moving, coordination between breathing and swallowing was also included. The results of this study would serve as the clinical guidelines for proper feeding positions for different populations and for different food contents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Swallowing is not only an important function for life maintenance, but also for quality of life improvement. Statistics revealed that subjects with intellectual disability or multiple disabilities have problems in controlling muscle tone and maintaining posture. In such circumstances, these subjects experience problems during feeding or eating. The adjustment of seat inclination would help in feeding/eating process. However, the proper inclination angle should be evaluated by medical professionals, however, most caregivers do not know the influence of improper positioning therefore subjects suffer from possible choking risks. The aims of this study were to investigate the timing and coordination of swallowing and respiration in 4 different seat inclination angles, with liquid and bolus. In the first stage, the investigators intend to use a self-developed wearable device to measure the submandibular muscle surface EMG, the movement of thyroid cartilage and respiratory status of nasal cavity. This particular program could auto-analysis the onset and offset of duration, and the excursion and strength of thyroid cartilage will be calculated when it was moving, coordination between breathing and swallowing was also included. The measurement would be done in four seat inclination angles (5, 15, 30, 45) for each subject. The data collected between different conditions would be compared, and suggestions of ideal angles during swallowing would be made. The second stage is the design and development of a feedback-controlled seat angle adjustment device, based on the data collected. The results of this study would serve as the clinical guidelines for proper feeding positions for different populations and for different food contents. The ergonomic data would also provide references for assistive technology professionals and practitioners in device design and development.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Typical-developed:

1. ages ranged from 20 to 60 years old,

People with disabilities:

  1. ages ranged from 20 to 60 years old,
  2. usually a need for supplementary feeding.

Exclusion criteria:

  • Excluded conditions are cases of intubation and feeding, severely mentally retarded or autistic cases that cannot express comfort, cases of frequent choking, and those who have been treated with a throat tube and have a narrow throat.
  • Exclude subjects who have undergone throat or nasal cavity surgery or have abnormalities in these two parts

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: angle 5 + 1ml water
The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 5 + 5 ml water
The measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 5 + 5 ml pudding
The measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 15 + 1ml water
The measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 15 + 5 ml water
The measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 15 + 5 ml pudding
The measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 30 + 1ml water
The measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 30 + 5 ml water
The measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 30 + 5 ml pudding
The measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 45 + 1ml water
The measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 45 + 5 ml water
The measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types
Active Comparator: angle 45 + 5 ml pudding
The measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake.
Behavioral: angle of inclination
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
Other: food type
the swallowing was tested with 3 food types

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electromyography
Time Frame: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
Two electrodes were attached to the submandibular muscle to register the electric potential generated by the muscles.
5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
thyroid cartilage excursion
Time Frame: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
A force-sensing resistor (FSR) was fixed over the larynx at the thyroid cartilage position with an elastic belt to detect the cartilage excursion.
5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
nasal airflow
Time Frame: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
A nasal airflow cannula was placed in front of the nasal cavity and was connected to a pressure transducer (Pro-Tech Services, Murrysville, PA, USA) to detect exhalation and inhalation.
5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsin-Yi K Cheng, PhD, Chang Gung University, Chang Gung Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201600752A3

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.

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