← Back to Search

Procedure

Swallowing Therapy App for Parkinson's Disease

Phase 1

Waitlist Available

Led By Stephanie Watts, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-12 weeks of intervention

Awards & highlights

Study Summary

This trial investigates if BiSSKit app can improve swallowing safety, pharyngeal kinematics, and swallowing-related quality of life in Parkinson's patients with dysphagia. 30 participants will be randomized to two groups for 12 weekly therapy sessions.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease, diagnosed by a specialist and showing swallowing difficulties. They must be able to consent to the study themselves. People with cognitive issues that prevent self-consent, history of stroke or brain injury, or prior dysphagia treatment cannot join.Check my eligibility

What is being tested?

The study compares traditional behavioral swallowing therapy against a new tablet app called i-BiSSkApp designed for home use. Participants will receive one of these therapies randomly and have their swallowing function tested before and after the 12-week program.See study design

What are the potential side effects?

Since this trial involves non-invasive therapy methods rather than medication, side effects are minimal but may include discomfort from regular exercises and potential frustration or fatigue associated with learning new technology.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-12 weeks of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-12 weeks of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-12 weeks of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Penetration Aspiration Scale Score (PAS)

Total Pharyngeal Residue

Secondary outcome measures

Eating Assessment Tool-10 (EAT-10)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: i-BiSSkApp GroupExperimental Treatment1 Intervention

This group will complete daily swallowing behavioral exercises with simultaneous at-home sEMG biofeedback using a tablet application. Participants will participate in weekly clinic visits and at-home therapy for 12 weeks.

Group II: Traditional TreatmentActive Control1 Intervention

This group will receive traditional swallowing therapy once a week for 12 weeks using standard therapy practices. They will also complete at-home daily practice of these exercises.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

412 Previous Clinical Trials

187,019 Total Patients Enrolled

Stephanie Watts, PhDPrincipal InvestigatorUniversity of South Florida

Media Library

i-BiSSkApp (tablet application) with swallowing therapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05837520 — Phase 1

Parkinson's Disease Research Study Groups: i-BiSSkApp Group, Traditional Treatment

Parkinson's Disease Clinical Trial 2023: i-BiSSkApp (tablet application) with swallowing therapy Highlights & Side Effects. Trial Name: NCT05837520 — Phase 1

i-BiSSkApp (tablet application) with swallowing therapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837520 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria for individuals who are able to join this research project?

"This clinical trial is seeking 40 patients with Parkinson's disease, aged 18-99. Acceptance to the study will depend on whether a patient meets these criteria."

Answered by AI

Does the age criterion extend beyond 25 years for this experiment?

"To be considered for this medical study, prospective patients must fall between the age brackets of 18 and 99 years old. There are 26 corresponding studies available to those below 18 while 497 clinical trials exist for elderly individuals over 65."

Answered by AI

Has the i-BiSSkApp Group been granted clearance by the FDA?

"There is limited clinical evidence backing the safety and efficacy of i-BiSSkApp Group, so it received a score of 1."

Answered by AI

Is enrollment for this clinical research still open?

"Contrary to expectation, clinicaltrials.gov has indicated that this medical trial is not currently recruiting patients - the study was first posted on June 15th 2023 and last edited on April 19th 2023. Nevertheless, there are 500 other trials actively enrolling individuals right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease

2023. "i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837520.