Trial Outcomes & Findings for Wearable Monitoring Systems for Swallowing Function and Disorders (NCT NCT04243577)
NCT ID: NCT04243577
Last Updated: 2024-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Post each experiment (i.e., 1 hour after the sensors have been placed)
Results posted on
2024-08-14
Participant Flow
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.
For iteration 1, 40 of the 51 participants were randomized into one of 2 groups for testing 1. Of those not randomized, 7 did not meet inclusion criteria, 1 declined to participate, and 1 did not participate due to other reasons (scheduling conflicts or technical issues). For iteration 2, 30 of the 38 participants were randomized into one of 2 groups for testing 2. Of those not randomized, 7 did not meet inclusion criteria, and 1 did not participate due to other reasons (technical issues).
Participant milestones
| Measure |
Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1
Group A1 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 1: A first iteration of a wearable surface EMG (sEMG) sensors patch we developed was 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. Participants performed standardized swallow tasks while wearing the first iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors
Group B1 participants completed the experimental protocol (swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors -Iteration 1: The first iteration of a wearable surface EMG (sEMG) sensors patch we developed was 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. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2
Group A2 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 2: A second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the second iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors
Group B2 participants completed the experimental protocol (swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors - Iteration 2: The second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
|---|---|---|---|---|
|
First Intervention (1 Hour)
STARTED
|
20
|
20
|
15
|
15
|
|
First Intervention (1 Hour)
COMPLETED
|
20
|
20
|
15
|
15
|
|
First Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (10 Minutes)
STARTED
|
20
|
20
|
15
|
15
|
|
Washout (10 Minutes)
COMPLETED
|
20
|
20
|
15
|
15
|
|
Washout (10 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Hour)
STARTED
|
20
|
20
|
15
|
15
|
|
Second Intervention (1 Hour)
COMPLETED
|
20
|
20
|
15
|
15
|
|
Second Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wearable Monitoring Systems for Swallowing Function and Disorders
Baseline characteristics by cohort
| Measure |
Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1
n=20 Participants
Group A1 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 1: A first iteration of a wearable surface EMG (sEMG) sensors patch we developed was 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. Participants performed standardized swallow tasks while wearing the first iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors
n=20 Participants
Group B1 participants completed the experimental protocol (swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors -Iteration 1: The first iteration of a wearable surface EMG (sEMG) sensors patch we developed was 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. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2
n=15 Participants
Group A2 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 2: A second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the second iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors
n=15 Participants
Group B2 participants completed the experimental protocol (swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors - Iteration 2: The second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
68.3 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
65.7 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
66.3 Years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Post each experiment (i.e., 1 hour after the sensors have been placed)Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants.
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.
Outcome measures
| Measure |
Conventional Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the conventional sensors during iteration testing 1 .
|
Tele-EaT Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the first version of the experimental (Tele-EaT) sensors during iteration testing 1.
|
Conventional Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the conventional sensors during iteration testing 2.
|
Tele-EaT Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the second version of the experimental (Tele-EaT) sensors during iteration testing 2.
|
|---|---|---|---|---|
|
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
|
12.5 percentage of maximum amplitude
Standard Deviation 7
|
11.7 percentage of maximum amplitude
Standard Deviation 7.3
|
17.3 percentage of maximum amplitude
Standard Deviation 8
|
13.8 percentage of maximum amplitude
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: Post each experiment (i.e., 1 hour after the sensors have been placed)Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants.
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.
Outcome measures
| Measure |
Conventional Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the conventional sensors during iteration testing 1 .
|
Tele-EaT Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the first version of the experimental (Tele-EaT) sensors during iteration testing 1.
|
Conventional Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the conventional sensors during iteration testing 2.
|
Tele-EaT Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the second version of the experimental (Tele-EaT) sensors during iteration testing 2.
|
|---|---|---|---|---|
|
Signal to Noise Ratio (Signal Quality Parameter)
|
19.5 Signal to noise ratio
Standard Deviation 5.2
|
20.4 Signal to noise ratio
Standard Deviation 5
|
25.1 Signal to noise ratio
Standard Deviation 5.5
|
26.7 Signal to noise ratio
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Post each experiment (i.e., 1 hour after the sensors have been placed)Population: The first iteration test of the Tele-EaT sensors against commercial/conventional sensors included 40 participants. The second iteration testing was tested in an additional 30 participants.
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).
Outcome measures
| Measure |
Conventional Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the conventional sensors during iteration testing 1 .
|
Tele-EaT Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the first version of the experimental (Tele-EaT) sensors during iteration testing 1.
|
Conventional Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the conventional sensors during iteration testing 2.
|
Tele-EaT Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the second version of the experimental (Tele-EaT) sensors during iteration testing 2.
|
|---|---|---|---|---|
|
Ease of Use/Comfort
|
48.06 score on a scale
Standard Deviation 3.6
|
48.62 score on a scale
Standard Deviation 3.2
|
54 score on a scale
Standard Deviation 8.3
|
57 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 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)Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants. For this outcome measure, cumulative data across both time points are presented.
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.
Outcome measures
| Measure |
Conventional Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the conventional sensors during iteration testing 1 .
|
Tele-EaT Sensors - Iteration Testing 1
n=40 Participants
Outcomes measured while using the first version of the experimental (Tele-EaT) sensors during iteration testing 1.
|
Conventional Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the conventional sensors during iteration testing 2.
|
Tele-EaT Sensors - Iteration Testing 2
n=30 Participants
Outcomes measured while using the second version of the experimental (Tele-EaT) sensors during iteration testing 2.
|
|---|---|---|---|---|
|
Adverse Effects and Safety
|
8 Participants
|
1 Participants
|
12 Participants
|
4 Participants
|
Adverse Events
Conventional Sensors - Iteration Testing 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Tele-EaT Sensors - Iteration Testing 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conventional Sensors - Iteration Testing 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Tele-EaT Sensors - Iteration Testing 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Sensors - Iteration Testing 1
n=40 participants at risk
Outcomes measured while using the conventional sensors during iteration testing 1 .
|
Tele-EaT Sensors - Iteration Testing 1
n=40 participants at risk
Outcomes measured while using the first version of the experimental (Tele-EaT) sensors during iteration testing 1.
|
Conventional Sensors - Iteration Testing 2
n=30 participants at risk
Outcomes measured while using the conventional sensors during iteration testing 2.
|
Tele-EaT Sensors - Iteration Testing 2
n=30 participants at risk
Outcomes measured while using the second version of the experimental (Tele-EaT) sensors during iteration testing 2.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
0.00%
0/40 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
10.0%
3/30 • Number of events 3 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
0.00%
0/30 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
7.5%
3/40 • Number of events 3 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
0.00%
0/40 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
20.0%
6/30 • Number of events 6 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
|
Skin and subcutaneous tissue disorders
Pain
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
0.00%
0/40 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.
We collected potential adverse data on two relevant factors: skin irritation and pain. For skin irritation, a YES/NO binary visual inspection/observation form was completed for each of three items: redness, skin irritation, itchiness. For pain, a YES/NO binary observation form was completed. If the answer was yes at any point, the participants were asked to rate the pain level as well on a scale from 0-10.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place