Trunk Inclination on Respiratory-swallowing Coordination

NCT05221801 | Completed

• 1 other identifier: 201600752A3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Disabling Disease

Keywords

positioning; swallowing; respiration; sensors; disability; assistive device

Outcome Measures

Primary Outcomes (3)

• Electromyography

  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

  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

  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.

Study Arms (12)

angle 5 + 1ml water

ACTIVE COMPARATOR

The measurement would be done in seat inclination angles of 5 degrees with 1 ml water intake.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: angle of inclination; Other: food type

Interventions

angle of inclination BEHAVIORAL

The measurement would be done in seat inclination angles of 5,15,30,45 degrees.

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 type OTHER

the swallowing was tested with 3 food types

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Typical-developed:
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsin-Yi K Cheng, PhD

  Chang Gung University, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The measurement would be done in 4 seat inclination angles (5, 15, 30, 45) and for 3 different food types for each subject.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 3, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 3, 2022

Record last verified: 2017-01

Locations

TW (1)