Wearable Monitoring Systems for Swallowing Function and Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2023-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Application and Benefit Evaluation of Wearable Technology and Information Software-Based Psychological Stress Monitoring in Return-to-Work Healthcare for Injured Workers: A Longitudinal Study

NCT06977464

Injury Return to Work Mental Health

ENROLLING_BY_INVITATION NA

Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance

NCT00827749

Swallowing Disorders

COMPLETED EARLY_PHASE1

Cardiopulmonary Training in the Victims With Multiple Morbidities by Application of Novel Heart Rate Sensing Clothes

NCT04022590

Degeneration Muscle Multiple Morbidities Heart; Complications

UNKNOWN NA

Validation of Study in Respiratory Physiology and it Interactions

NCT01881945

Life Experiences Respiratory Function Cardiac Function

UNKNOWN NA

Functional Outcomes of Voice Recognition Prosthesis

NCT04595071

Prosthesis Amputation Prosthesis User

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deglutition Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors

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).

Group Type OTHER

Tele-EaT Sensors

Intervention Type DEVICE

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

Intervention Type 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.

Group B: Experimental (Tele-EaT) Sensors First, Then 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.

Group Type OTHER

Tele-EaT Sensors

Intervention Type DEVICE

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tele-EaT 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.

Intervention Type DEVICE

Conventional Sensors

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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).