Wearable Monitoring Systems for Swallowing Function and Disorders

Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders

Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders
• Intervention / Treatment: Device: Tele-EaT Sensors; Device: Conventional Sensors

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University I-EaT Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Inclusion criteria for healthy adults:

• Age 18-30 OR 50-90 years of age
• No history of dysphagia
• No history of a neurological disorder
• A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
• A score of <3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Inclusion criteria for patients with dysphagia:

• Age 18-90 years of age
• Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
• A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
• A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Exclusion Criteria:

• Significant cognitive impairment (a score in the moderate-severe range on MoCA):

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors; Group A participants will complete the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).	Device: Tele-EaT Sensors; Two iterations of a wearable surface EMG (sEMG) sensors patch we developed will be tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The second iteration is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants will perform standardized swallow tasks while wearing the device.; Device: Conventional Sensors; Conventional sensors will include snap-on wired electrodes as the control condition. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.
Other: Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors; Group B participants will complete the experimental protocol (swallow trials) with the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then will repeat the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.	Device: Tele-EaT Sensors; Two iterations of a wearable surface EMG (sEMG) sensors patch we developed will be tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The second iteration is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants will perform standardized swallow tasks while wearing the device.; Device: Conventional Sensors; Conventional sensors will include snap-on wired electrodes as the control condition. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)	Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.	Post each experiment (i.e., 1 hour after the sensors have been placed)
Signal to Noise Ratio (Signal Quality Parameter)	Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.	Post each experiment (i.e., 1 hour after the sensors have been placed)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use/Comfort	Ease-of-use/comfort will be examined using a survey also devised by the investigators (using a positive centered 5-point Likert scale) with questions about ease-of-use/comfort after each experiment with each device. This survey includes statements related to the participants' ease-of-use/comfort during the experimental protocol (e.g., I was comfortable while the experimenter placed the sensors on my skin). The answers will be rated on a 10-point scale (i.e., 1 = extremely uncomfortable, 10 = extremely comfortable). Higher values indicate better or higher satisfaction/comfort scores. Total scores will be compared across conditions/devices tested. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).	Post each experiment (i.e., 1 hour after the sensors have been placed)
Adverse Effects and Safety	Safety will be examined by documenting the incidence of skin irritations and pain in the subjects. A visual inspection form including a binary scale (YES/NO) has been devised by the investigators (no formal name) and will be used by a rater who will thoroughly inspect the participants' submandibular skin before and after each experiment. For any irritation or change in appearance YES will be selected and the type of irritation will be descriptively recorded (e.g., red skin). Pain is also rated in the same way through a question to the participants. This form will be completed by a rater who is not part of the data collection process and who is blinded to sensors type to avoid any bias.The number of YESs will be used to calculate the incidence of these adverse effects in the sample.	Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal)

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Georgia A. Malandraki, PhD, Professor; Principal Investigator: Chi Hwan Lee, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 1807020788; 1R21EB026099-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes