Wearable Monitoring Systems for Swallowing Function and Disorders
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|ClinicalTrials.gov Identifier: NCT04243577|
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Deglutition Disorders||Device: Tele-EaT Sensors Device: Conventional Sensors||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
|Official Title:||Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders|
|Actual Study Start Date :||September 11, 2018|
|Estimated Primary Completion Date :||September 10, 2021|
|Estimated Study Completion Date :||September 10, 2024|
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.
- Normalized task-related sEMG amplitude (signal quality parameter) [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]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) [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]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) [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]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.
- Adverse effects and safety [ 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) ]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 [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]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 Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]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 Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]Time to reach peak pressure will be measured in seconds and is another temporal measure of interest.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243577
|Contact: Georgia Malandraki, PhDemail@example.com|
|Contact: Georgia A. Malandraki, PhDfirstname.lastname@example.org|
|Principal Investigator:||Georgia A. Malandraki, PhD||Associate Professor|
|Principal Investigator:||Chi Hwan Lee, PhD||Assistant Professor|