Deglutition DisordersEarly Phase 1NCT04243577

Wearable Monitoring Systems for Swallowing Function and Disorders

A Early Phase 1 study testing Tele-EaT Sensors and Conventional Sensors in people with Deglutition Disorders, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Deglutition Disorders
What is being tested?: Tele-EaT Sensors and Conventional Sensors
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2018to 25 Jul 2023
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).
Age 18-90 years of age

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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).

Who cannot join

Significant cognitive impairment (a score in the moderate-severe range on MoCA):

Trial locations and contacts

1 site in 1 country.

United States1 site

Purdue University I-EaT Lab
West Lafayette, Indiana, 47907

Other trials in United States

About this study

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

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.

Conditions: Deglutition Disorders
Being tested: Tele-EaT Sensors, Conventional Sensors
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tele-EaT SensorsDevice
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 SensorsDevice
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.

Study groups in NCT04243577
Study group	Role	What they receive
Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors	Other	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). Receives: Device: Tele-EaT Sensors; Device: Conventional Sensors
Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors	Other	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. Receives: Device: Tele-EaT Sensors; Device: Conventional Sensors

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Post each experiment (i.e., 1 hour after the sensors have been placed)

Secondary outcomes (2)

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).
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201825 Jul 2023

First posted28 Jan 2020
Study start11 Sep 2018
Primary completion31 Mar 2023
Study completion25 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Deglutition DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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 blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04243577
Sponsor's protocol ID: 1807020788
Other IDs: 1R21EB026099-01A1
Status last verified: Jul 2024
First submitted: 26 Aug 2019
Last updated: 14 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Deglutition Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
ClinicalTrials.gov ID: NCT04243577
Acronym / sponsor ID: 1807020788
Conditions: Deglutition Disorders
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Purdue UniversityUniversity, hospital or other
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Study start: 11 Sep 2018 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 25 Jul 2023 (actual)
First posted: 28 Jan 2020 (actual)
Results: Posted 14 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors	Other	Device: Tele-EaT Sensors, Device: Conventional SensorsGroup 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).
Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors	Other	Device: Tele-EaT Sensors, Device: Conventional SensorsGroup 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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).

Key exclusion criteria (1 listed)

Significant cognitive impairment (a score in the moderate-severe range on MoCA):

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tele-EaT SensorsTwo 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.	Device	Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors, Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors
Conventional SensorsConventional 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.	Device	Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors, Group B: Experimental (Tele-EaT) Sensors First, Then Conventional Sensors

Primary outcome

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.
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 tested. Signal to noise ration is a signal quality parameter and not a health related outcome.

2 secondary outcomes

Ease of Use/Comfort
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
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)

Results and safety

Results posted to the registry on 14 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1	20	20
Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors	20	20
Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2	15	15
Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors	15	15

Primary outcome: Normalized Task-related sEMG Amplitude (Signal Quality Parameter)

Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed). Mean (Standard Deviation). Unit: percentage of maximum amplitude

Measure	Conventional Sensors - Iteration Testing 1 n = 40	Tele-EaT Sensors - Iteration Testing 1 n = 40	Conventional Sensors - Iteration Testing 2 n = 30	Tele-EaT Sensors - Iteration Testing 2 n = 30
Value	12.5 (7)	11.7 (7.3)	17.3 (8)	13.8 (6.2)

Conventional Sensors - Iteration Testing 1 vs Tele-EaT Sensors - Iteration Testing 1: p <0.025, t-test, 2 sided
Conventional Sensors - Iteration Testing 2 vs Tele-EaT Sensors - Iteration Testing 2: p <0.025, Bootstrapping CIs

Population analysed: 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.

Primary outcome: Signal to Noise Ratio (Signal Quality Parameter)

Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed). Mean (Standard Deviation). Unit: Signal to noise ratio

Measure	Conventional Sensors - Iteration Testing 1 n = 40	Tele-EaT Sensors - Iteration Testing 1 n = 40	Conventional Sensors - Iteration Testing 2 n = 30	Tele-EaT Sensors - Iteration Testing 2 n = 30
Value	19.5 (5.2)	20.4 (5)	25.1 (5.5)	26.7 (3.9)

Conventional Sensors - Iteration Testing 1 vs Tele-EaT Sensors - Iteration Testing 1: p <0.025, t-test, 1 sided
Conventional Sensors - Iteration Testing 2 vs Tele-EaT Sensors - Iteration Testing 2: p <0.025, Bootstrapping CIs

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected immediately after removal of each sensors type (post each experiment) and 5 minutes later as well.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Sensors - Iteration Testing 1	0 of 40 (0%)	8 of 40 (20%)	0 of 40
Tele-EaT Sensors - Iteration Testing 1	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40
Conventional Sensors - Iteration Testing 2	0 of 30 (0%)	12 of 30 (40%)	0 of 30
Tele-EaT Sensors - Iteration Testing 2	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Georgia A. Malandraki, PhD principal investigator

Professor

Chi Hwan Lee, PhD principal investigator

Associate Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tele-EaT Sensors and Conventional Sensors in people with Deglutition Disorders, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Normalized Task-related sEMG Amplitude (Signal Quality Parameter) (time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.