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): 102
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Georgia Malandraki, PhD; Phone Number: 765-496-0207; Email: swallowinglab@purdue.edu
• Study Contact Backup: Name: Georgia A. Malandraki, PhD; Phone Number: 765-496-0206; Email: malandraki@purdue.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 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
Experimental: Experimental Sensors; This arm will include the use of the experimental wearable sensors we are developing.	Device: Tele-EaT Sensors; Several iterations of a wearable surface EMG sensors patch and a wearable intra-oral lingual press device that we will develop, will be tested against commercially available wired devices. The wearable sensor patch will be an ultrathin patch with a honeycomb-inspired design that includes 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 wearable intra-oral device will integrate a wireless intraoral sensor system that will allow simultaneous recording of lingual pressure and movement during swallows and lingual tasks in a wireless fashion. Participants will perform standardized swallow tasks with both devices.
Active Comparator: Conventional Sensors; This arm will include the use of the conventional sensors: regular snap on sEMG electrodes and IOPI device bulb.	Device: Conventional Sensors; Conventional sensors will include snap-on wired electrodes and the use of the Iowa Oral Performance Instrument as the control conditions. 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)
Peak pressure during maximum lingual press and swallows (signal quality parameter)	The peak pressure achieved during maximum lingual presses and during swallows will be recorded and compared between the two lingual press devices tested. Peak pressure is used here as a signal quality parameter and not as 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 for both the sEMG and the lingual press devices 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
Adverse effects and safety	Safety will be examined by documenting the incidence of skin and intraoral irritations 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 and intraoral cavity 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). 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)
Ease of use/comfort	Ease-of-use/comfort will be examined using a 10-item 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 or in my mouth). 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.	Post each experiment (i.e., 1 hour after the sensors have been placed)
Onset of sEMG activity relative to onset of swallow apnea	Time of onset of sEMG activity relative to the time of onset of swallow apnea will be calculated for each task and device. This variable will serve as a timing measure to help us evaluate the temporal sensitivity of the systems.	Post each experiment (i.e., 1 hour after the sensors have been placed)
Time to reach peak pressure	Time to reach peak pressure will be measured in seconds and is another temporal measure of interest.	Post each experiment (i.e., 1 hour after the sensors have been placed)

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Georgia A. Malandraki, PhD, Associate Professor; Principal Investigator: Chi Hwan Lee, PhD, Assistant 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): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

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