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NCT04664634 Clinical Trial

Therapeutic Swallow Sensor

Parkinson Disease Clinical Trial

Official title:
Novel Sensor for Swallowing in Patients With Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04664634
Other study ID # STU00212981
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date June 30, 2024

Study information
Verified date October 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 26
Est. completion date June 30, 2024
Est. primary completion date November 22, 2021
Accepts healthy volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - =21 years of age - PD patients of any severity - Evidence of mild to moderate oropharyngeal dysphagia as determined by an SLP Exclusion Criteria: - Patients cannot safely swallow at least one bolus of liquid without risk of aspiration - End stage dementia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Northwestern University Evanston Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent agreement with Gold Standard Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring) 1 year
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