Wearable Monitoring Systems for Swallowing Function and Disorders

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243577
• Other study ID #: 1807020788
• Secondary ID: 1R21EB026099-01A
• Status: Completed
• Phase: Early Phase 1
• Start date: September 11, 2018
• Est. completion date: July 25, 2023

Study information

• Verified date: July 2023
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 25, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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):

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University I-EaT Lab	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)