Clinical trial NCT04664634: A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Official title: A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dysphagia
Parkinson Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Percent agreement with Gold Standard
timeFrame: 1 year
measure: Change in mean swallow frequency during haptic cueing week
timeFrame: Week 1 to Week 2
Secondary outcomes:
measure: Change in algorithm-detected swallow frequency during haptic cueing week
timeFrame: Week 1 to Week 2
measure: Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score
timeFrame: Baseline to Week 3
measure: Change in ROMP-Swallowing Subscale score
timeFrame: Baseline to Week 3
measure: Change in participant adherence to haptic cueing
timeFrame: Week 2
Other outcomes:
measure: Change in Modified Barium Swallow Impairment Profile (MBSImP)
timeFrame: Baseline to Week 3
measure: Change in Penetration-Aspiration Scale Score
timeFrame: Baseline to Week 3
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: