Therapeutic Swallow Sensor
- Conditions
- DysphagiaParkinson Disease
- Registration Number
- NCT04664634
- Lead Sponsor
- Northwestern University
- Brief Summary
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
- Detailed Description
The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD. The first phase of the program involves engineering goals relating to increasing the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. The second phase of the program is to conduct focus groups with PD patients to assess sensor usability, set up burden, and design feedback. The third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of PD patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 26
- ≥21 years of age
- PD patients of any severity
- Evidence of mild to moderate oropharyngeal dysphagia as determined by an SLP
- Patients cannot safely swallow at least one bolus of liquid without risk of aspiration
- End stage dementia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent agreement with Gold Standard 1 year Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Evanston, Illinois, United States