Wearable Monitoring Systems for Swallowing Function and Disorders

NCT04243577 | Completed Early Phase 1 Results FDA Device

• 2 other identifiers: 18070207881R21EB026099-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ease of Use/Comfort

  Post each experiment (i.e., 1 hour after the sensors have been placed)

• Adverse Effects and Safety

  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)

Study Arms (2)

Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors

OTHER

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; Device: Conventional Sensors

Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors

OTHER

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; Device: Conventional Sensors

Interventions

Tele-EaT Sensors DEVICE

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.

Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors; Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors

Conventional Sensors DEVICE

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.

Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors; Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Purdue University: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Purdue University I-EaT Lab

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Georgia Malandraki
• Organization: Purdue University

malandraki@purdue.edu

7654960206

Study Officials

• Georgia A. Malandraki, PhD

  Professor

  PRINCIPAL INVESTIGATOR

• Chi Hwan Lee, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Speech, Language and Hearing Sciences

Model Details: Experiments will follow a within-subject randomized cross-over design. The purpose is to develop devices that are optimized for their use. To achieve this goal, for each new iteration of the devices, at least ten new participants will be tested using the current prototypes and the commercially available counterpart sensors in counterbalanced order. Results will be analyzed and discussed in regards to design improvements before the next iteration of development. The plan to recruit a large number of total subjects allows for several pre-clinical experiments to be conducted until the final versions of both devices are optimized.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: January 28, 2020
• Study Start: September 11, 2018
• Primary Completion: March 31, 2023
• Study Completion: July 25, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Locations

US (1)