Disabling DiseaseNCT05221801
Trunk Inclination on Respiratory-swallowing Coordination
A study testing angle of inclination and food type in people with Disabling Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Disabling Disease
- What is being tested?
- angle of inclination and food type
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Typical-developed:
- 1. ages ranged from 20 to 60 years old,
- People with disabilities:
- ages ranged from 20 to 60 years old,
- usually a need for supplementary feeding.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disabling Disease
- Being tested
- angle of inclination, food type
- Keywords
- positioning, swallowing, respiration, sensors, disability, assistive device
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angle of inclinationBehavioural
The measurement would be done in seat inclination angles of 5,15,30,45 degrees.
food typeOther
the swallowing was tested with 3 food types
| Study group | Role | What they receive |
|---|---|---|
| angle 5 + 1ml water | Active comparator | The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 5 + 5 ml water | Active comparator | The measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 5 + 5 ml pudding | Active comparator | The measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 15 + 1ml water | Active comparator | The measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 15 + 5 ml water | Active comparator | The measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 15 + 5 ml pudding | Active comparator | The measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 30 + 1ml water | Active comparator | The measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 30 + 5 ml water | Active comparator | The measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 30 + 5 ml pudding | Active comparator | The measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 45 + 1ml water | Active comparator | The measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 45 + 5 ml water | Active comparator | The measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake. Receives: Behavioral: angle of inclination; Other: food type |
| angle 45 + 5 ml pudding | Active comparator | The measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake. Receives: Behavioral: angle of inclination; Other: food type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
Two electrodes were attached to the submandibular muscle to register the electric potential generated by the muscles.
Measured: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
thyroid cartilage excursion
A force-sensing resistor (FSR) was fixed over the larynx at the thyroid cartilage position with an elastic belt to detect the cartilage excursion.
Measured: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
nasal airflow
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.
Measured: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabling DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The measurement would be done in 4 seat inclination angles (5, 15, 30, 45) and for 3 different food types for each subject.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsin-Yi K Cheng, PhD, Principal investigator, Chang Gung University, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221801
- Sponsor's protocol ID
- 201600752A3
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Inclination Angle on Swallowing/Respiratory Function and the Development of Smart Positioning-angle Adjustment Device
- ClinicalTrials.gov ID
- NCT05221801
- Acronym / sponsor ID
- 201600752A3
- Conditions
- Disabling Disease
- Keywords
- positioning, swallowing, respiration, sensors, disability, assistive device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Feb 2022 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- The measurement would be done in 4 seat inclination angles (5, 15, 30, 45) and for 3 different food types for each subject.
| Arm | Type | Receives |
|---|---|---|
| angle 5 + 1ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake. |
| angle 5 + 5 ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 5 degrees with 5 ml water intake. |
| angle 5 + 5 ml pudding | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 5 degrees with 5 ml pudding intake. |
| angle 15 + 1ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 15 degrees with 1 ml water intake. |
| angle 15 + 5 ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 15 degrees with 5 ml water intake. |
| angle 15 + 5 ml pudding | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 15 degrees with 5 ml pudding intake. |
| angle 30 + 1ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 30 degrees with 1 ml water intake. |
| angle 30 + 5 ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 30 degrees with 5 ml water intake. |
| angle 30 + 5 ml pudding | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 30 degrees with 5 ml pudding intake. |
| angle 45 + 1ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 45 degrees with 1 ml water intake. |
| angle 45 + 5 ml water | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 45 degrees with 5 ml water intake. |
| angle 45 + 5 ml pudding | Active comparator | Behavioral: angle of inclination, Other: food typeThe measurement would be done in seat inclination angles of 45 degrees with 5 ml pudding intake. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. ages ranged from 20 to 60 years old,
- ages ranged from 20 to 60 years old,
- usually a need for supplementary feeding.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| angle of inclinationThe measurement would be done in seat inclination angles of 5,15,30,45 degrees. | Behavioural | angle 15 + 1ml water, angle 15 + 5 ml pudding, angle 15 + 5 ml water, angle 30 + 1ml water, angle 30 + 5 ml pudding, angle 30 + 5 ml water, angle 45 + 1ml water, angle 45 + 5 ml pudding, angle 45 + 5 ml water, angle 5 + 1ml water, angle 5 + 5 ml pudding, angle 5 + 5 ml water |
| food typethe swallowing was tested with 3 food types | Other | angle 15 + 1ml water, angle 15 + 5 ml pudding, angle 15 + 5 ml water, angle 30 + 1ml water, angle 30 + 5 ml pudding, angle 30 + 5 ml water, angle 45 + 1ml water, angle 45 + 5 ml pudding, angle 45 + 5 ml water, angle 5 + 1ml water, angle 5 + 5 ml pudding, angle 5 + 5 ml water |
Primary outcome
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.
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.
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.
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 3 Feb 2022.
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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.
Hsin-Yi K Cheng, PhD principal investigator
Chang Gung University, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angle of inclination and food type in people with Disabling Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 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 3 Feb 2022. 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 Taiwan. 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?
Electromyography (time frame: 5 seconds before the beginning of the swallow to 5 seconds after the end of the swallow.). The study lists 3 primary outcomes in all. 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 3 Feb 2022.