Back to resultsWearable Monitoring Systems for Swallowing Function and Disorders
Primary Purpose
Deglutition Disorders
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tele-EaT Sensors
Conventional Sensors
Sponsored by
About this trial
This is an interventional other trial for Deglutition Disorders
Eligibility Criteria
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):
Sites / Locations
- Purdue University I-EaT Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Sensors
Conventional Sensors
Arm Description
This arm will include the use of the experimental wearable sensors we are developing.
This arm will include the use of the conventional sensors: regular snap on sEMG electrodes and IOPI device bulb.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Time to reach peak pressure
Time to reach peak pressure will be measured in seconds and is another temporal measure of interest.
Full Information
NCT ID
NCT04243577
First Posted
August 26, 2019
Last Updated
July 26, 2023
Sponsor
Purdue University
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT04243577
Brief Title
Wearable Monitoring Systems for Swallowing Function and Disorders
Official Title
Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Sensors
Arm Type
Experimental
Arm Description
This arm will include the use of the experimental wearable sensors we are developing.
Arm Title
Conventional Sensors
Arm Type
Active Comparator
Arm Description
This arm will include the use of the conventional sensors: regular snap on sEMG electrodes and IOPI device bulb.
Intervention Type
Device
Intervention Name(s)
Tele-EaT Sensors
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional Sensors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Normalized task-related sEMG amplitude (signal quality parameter)
Description
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.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
Title
Peak pressure during maximum lingual press and swallows (signal quality parameter)
Description
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.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
Title
Signal to Noise ratio (signal quality parameter)
Description
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.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
Secondary Outcome Measure Information:
Title
Adverse effects and safety
Description
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.
Time Frame
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)
Title
Ease of use/comfort
Description
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.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
Title
Onset of sEMG activity relative to onset of swallow apnea
Description
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.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
Title
Time to reach peak pressure
Description
Time to reach peak pressure will be measured in seconds and is another temporal measure of interest.
Time Frame
Post each experiment (i.e., 1 hour after the sensors have been placed)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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):
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia A. Malandraki, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi Hwan Lee, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University I-EaT Lab
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Wearable Monitoring Systems for Swallowing Function and Disorders
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