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Wearable Biofeedback for Swallowing Disorders

N/A

Waitlist Available

Led By Georgia Malandraki, PhD

Research Sponsored by Purdue University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 50-90 years old

Confirmed oropharyngeal dysphagia evaluated by a certified and trained Speech Language Pathologist (SLP) during the intervention eligibility assessment

Must not have

Known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract

Facial hair in the submental area and refusal to shave

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new technology called i-Phagia, which provides biofeedback to patients with swallowing difficulties due to conditions like stroke or Parkinson's disease. The researchers want to see if

Who is the study for?

This trial is for individuals with swallowing difficulties after a stroke or those diagnosed with Parkinson's Disease. Participants will undergo a 12-week swallow therapy protocol and must be able to attend three in-person evaluations. They should also commit to exercising at home and maintaining an exercise diary.

What is being tested?

The study tests if using wearable biofeedback technology (i-Phagia) alongside standard swallow therapy improves swallowing function better than standard treatment alone, both in-person and via telehealth. It also examines which patient factors affect the success of the treatment.

What are the potential side effects?

Since this trial involves non-invasive biofeedback technology and standard therapy exercises, significant side effects are not anticipated. However, participants may experience discomfort from wearing the device or fatigue from the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

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My swallowing difficulty has been confirmed by a speech therapist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to barium or have a blockage in my digestive system.

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I have facial hair under my chin and choose not to shave it.

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I have had surgery, radiation, or trauma to my head or neck.

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I do not have conditions like multiple sclerosis or brain tumors.

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I have trouble swallowing safely without choking, as confirmed by a speech therapist.

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I am currently in therapy for swallowing or speech.

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I don't have trouble swallowing as assessed by a speech therapist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Oral Intake Scale (FOIS)

Normalized sEMG amplitude

Penetration-Aspiration Scale (PAS)

Secondary study objectives

Patient Satisfaction

Swallowing-related Quality of Life (SWAL-QOL)

Treatment adherence

Other study objectives

Stimulability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard-of-Care (SOC) Swallow TreatmentExperimental Treatment1 Intervention

The treatment group assigned to the SOC service delivery will complete the same standardized swallowing rehabilitation protocol and in the same frequency as the i-Phagia groups but without the device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week.

Group II: IN-person i-PhagiaExperimental Treatment1 Intervention

The treatment group assigned to the IN-PERSON i-Phagia service delivery will use the system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week.

Group III: Remote i-PhagiaActive Control1 Intervention

The treatment group assigned to the REMOTE i-Phagia service delivery will use the i-Phagia system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard-of-care treatment

2018

N/A

~120

0 / 9Eligibility criteria met