i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease
Public ClinicalTrials.gov record NCT05837520. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
At-Home Skill Training Using Biofeedback for Swallowing Rehabilitation in Parkinson's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.
Study identification
- NCT ID
- NCT05837520
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- i-BiSSkApp (tablet application) with swallowing therapy Device
- Traditional behavioral swallowing therapy Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2023 (Estimated)
- Primary completion
- May 31, 2024 (Estimated)
- Completion
- May 31, 2024 (Estimated)
- Last update posted
- May 1, 2023
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univerity of South Florida | Tampa | Florida | 33612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05837520, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05837520 live on ClinicalTrials.gov.