A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's

Phase 3

Recruiting

• Conditions: Dysphagia; Parkinson 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.

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Status Verified: 2024-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)
Change in mean swallow frequency during haptic cueing week	Week 1 to Week 2	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score	Baseline to Week 3	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.
Change in ROMP-Swallowing Subscale score	Baseline to Week 3	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.
Change in algorithm-detected swallow frequency during haptic cueing week	Week 1 to Week 2	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.
Change in participant adherence to haptic cueing	Week 2	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Evanston, Illinois, United States