The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
The Aria sensor is a wearable patch that continuously monitors physiological signals and provides vibratory haptic cues to increase swallow frequency. The intervention consists of using the sensor over a 3-week period, with active haptic cueing during Week 2 only.
Northwestern University
Evanston, Illinois, United States
RECRUITINGPercent agreement with Gold Standard
Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)
Time frame: 1 year
Change in mean swallow frequency during haptic cueing week
This outcome measures the change in the average number of swallows per hour during the intervention week (Week 2, with haptic cueing) compared to baseline (Week 1, no cueing). Swallows will be manually labeled from sensor audio recordings by at least three independent annotators.
Time frame: Week 1 to Week 2
Change in algorithm-detected swallow frequency during haptic cueing week
This outcome measures the change in the mean swallow frequency as automatically detected by the Aria sensor's AI algorithm, comparing Week 2 (intervention) to Week 1 (baseline). Performance will be benchmarked against manually annotated swallows.
Time frame: Week 1 to Week 2
Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score
Assesses the effect of the intervention on drooling symptoms using the Sialorrhea Clinical Scale for PD. Participants complete this validated questionnaire at baseline, during, and after the intervention.
Time frame: Baseline to Week 3
Change in ROMP-Swallowing Subscale score
Assesses changes in self-reported swallowing function using the Swallowing Subscale of the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP). The ROMP is a validated, PD-specific measure.
Time frame: Baseline to Week 3
Change in participant adherence to haptic cueing
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Evaluates adherence to the intervention by quantifying the percentage of haptic cues that are followed by a swallow within 5 seconds during Week 2. Cue-swallow pairings are based on algorithmic and manual labeling.
Time frame: Week 2