A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aria Sensor.
- Who it may be relevant to
- Registry conditions: Dysphagia, Parkinson Disease. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Aria Sensor
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.
Primary outcome measures
- Percent agreement with Gold Standard [Time frame: 1 year]
- Change in mean swallow frequency during haptic cueing week [Time frame: Week 1 to Week 2]
Secondary outcome measures (4)
- Change in algorithm-detected swallow frequency during haptic cueing week [Time frame: Week 1 to Week 2]
- Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score [Time frame: Baseline to Week 3]
- Change in ROMP-Swallowing Subscale score [Time frame: Baseline to Week 3]
- Change in participant adherence to haptic cueing [Time frame: Week 2]
Eligibility criteria
Inclusion criteria. Age ≥22. English speaking. Diagnosis of idiopathic Parkinson's disease of any Hoehn and Yahr stage (I-V), determined by a neurologist.
Mild to moderate sialorrhea defined as a score of ≥ 11\* on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP)-Saliva (C) subscale Subjects must be in the "on" phase of their medication during all study assessments. The "on" phase is defined as the period when the participant's medication is at peak effectiveness, minimizing motor fluctuations and enabling optimal motor function.
Study Exclusion Criteria. History of aspiration pneumonia within the past 12 months. Unable to swallow saliva without a maneuver. Actively receiving treatment for swallowing disorders or sialorrhea. Current alcohol/drug abuse. Diagnosed with neurological disorders other than PD. End stage dementia. History of head and neck cancer or surgery. Unable to demonstrate competency with the user-friendly sensor platform technology.
Known allergy to contrast material used during MBSS. Known allergy to sensor adhesive. Indwelling tracheostomy tube. Nasogastric (NG) feeding tube. Currently pregnant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Northwestern University — Evanston
Identifiers
NCT: NCT04664634 · STU00221904