A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorNorthwestern University
About this trial
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Aria Sensor
DeviceThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent agreement with Gold Standard
Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)
Time frame
1 year2
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 2Secondary outcomes
1
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 22
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 33
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 34
Change in participant adherence to haptic cueing
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 2Other outcomes
1
Change in Modified Barium Swallow Impairment Profile (MBSImP)
Subsample of participants will undergo video fluoroscopy to evaluate swallowing function. The MBSImP scores will assess changes in swallow physiology pre- and post-intervention.
Time frame
Baseline to Week 32
Change in Penetration-Aspiration Scale Score
Assesses airway protection during swallowing via penetration-aspiration scale scores from videofluoroscopic studies in a subsample of participants.
Time frame
Baseline to Week 3Sponsors and contacts
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Source ClinicalTrials.gov