An Early Phase 1 interventional study of Tele-EaT Sensors and Conventional Sensors in Deglutition Disorders, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Purdue University · Early Phase 1, Interventional, and Other
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.
723 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 482 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Purdue University is the lead sponsor of 174 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for healthy adults:
Inclusion criteria for patients with dysphagia:
Exclusion Criteria:
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 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
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.
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.
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.
Time frame: 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.
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Ease of Use/Comfort
Ease-of-use/comfort will be examined using a 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). 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. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Adverse Effects and Safety
Safety will be examined by documenting the incidence of skin irritations and pain 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 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). Pain is also rated in the same way through a question to the participants. 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)
Two iterations of the sensors were tested against commercial sensors. For iteration 1, 51 healthy older adults were screened for eligibility between September and November 2018. For iteration 2, 38 healthy older adults were screened for eligibility between October 2021 and March 2023. All was completed at a university research lab and clinic in West Lafayette, Indiana.
| Milestone | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors |
|---|---|---|---|---|
| Started | 20 | 20 | 15 | 15 |
| Completed | 20 | 20 | 15 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors |
|---|---|---|---|---|
| Started | 20 | 20 | 15 | 15 |
| Completed | 20 | 20 | 15 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors |
|---|---|---|---|---|
| Started | 20 | 20 | 15 | 15 |
| Completed | 20 | 20 | 15 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| percentage of maximum amplitude | Conventional Sensors - Iteration Testing 1 | Tele-EaT Sensors - Iteration Testing 1 | Conventional Sensors - Iteration Testing 2 | Tele-EaT Sensors - Iteration Testing 2 |
|---|---|---|---|---|
| Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | 12.5 ± 7 | 11.7 ± 7.3 | 17.3 ± 8 | 13.8 ± 6.2 |
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.
| Signal to noise ratio | Conventional Sensors - Iteration Testing 1 | Tele-EaT Sensors - Iteration Testing 1 | Conventional Sensors - Iteration Testing 2 | Tele-EaT Sensors - Iteration Testing 2 |
|---|---|---|---|---|
| Signal to Noise Ratio (Signal Quality Parameter) | 19.5 ± 5.2 | 20.4 ± 5 | 25.1 ± 5.5 | 26.7 ± 3.9 |
Ease-of-use/comfort will be examined using a 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). 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. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).
| score on a scale | Conventional Sensors - Iteration Testing 1 | Tele-EaT Sensors - Iteration Testing 1 | Conventional Sensors - Iteration Testing 2 | Tele-EaT Sensors - Iteration Testing 2 |
|---|---|---|---|---|
| Ease of Use/Comfort | 48.06 ± 3.6 | 48.62 ± 3.2 | 54 ± 8.3 | 57 ± 4.2 |
Safety will be examined by documenting the incidence of skin irritations and pain 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 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). Pain is also rated in the same way through a question to the participants. 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.
| Participants | Conventional Sensors - Iteration Testing 1 | Tele-EaT Sensors - Iteration Testing 1 | Conventional Sensors - Iteration Testing 2 | Tele-EaT Sensors - Iteration Testing 2 |
|---|---|---|---|---|
| Adverse Effects and Safety | 8 | 1 | 12 | 4 |
Collected over Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Sensors - Iteration Testing 1 | 0/40 (0%) | 0/40 (0%) | 8/40 (20%) |
| Tele-EaT Sensors - Iteration Testing 1 | 0/40 (0%) | 0/40 (0%) | 1/40 (2.5%) |
| Conventional Sensors - Iteration Testing 2 | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| Tele-EaT Sensors - Iteration Testing 2 | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Event | Conventional Sensors - Iteration Testing 1 | Tele-EaT Sensors - Iteration Testing 1 | Conventional Sensors - Iteration Testing 2 | Tele-EaT Sensors - Iteration Testing 2 |
|---|---|---|---|---|
| Skin rednessSkin and subcutaneous tissue disorders | 3/40 | 0/40 | 6/30 | 2/30 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/40 | 0/40 | 3/30 | 0/30 |
| ItchinessSkin and subcutaneous tissue disorders | 2/40 | 1/40 | 2/30 | 1/30 |
| PainSkin and subcutaneous tissue disorders | 2/40 | 0/40 | 1/30 | 1/30 |
| Age, Continuous(Years) | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors | Total |
|---|---|---|---|---|---|
| Mean | 66.5 ± 8.8 | 68.3 ± 6.7 | 63.6 ± 10 | 65.7 ± 8.4 | 66.3 ± 8.5 |
| Sex: Female, Male(Participants) | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors | Total |
|---|---|---|---|---|---|
| Female | 5 | 11 | 7 | 6 | 29 |
| Male | 15 | 9 | 8 | 9 | 41 |
| Ethnicity (NIH/OMB)(Participants) | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 20 | 15 | 13 | 68 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 1 |
| White | 19 | 20 | 15 | 12 | 66 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors | Total |
|---|---|---|---|---|---|
| United States | 20 | 20 | 15 | 15 | 70 |
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Ran from Sep 2018 to primary completion in Mar 2023, 54 months.
Results were first posted in Aug 2024, 1 year 4 months after primary completion.
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