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Therapeutic Swallow Sensor

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ClinicalTrials.gov Identifier: NCT04664634
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Shuai (Steve) Xu, Northwestern University

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

Condition or disease
Dysphagia Parkinson Disease

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Sensor for Swallowing in Patients With Parkinson's Disease
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : August 14, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percent agreement with Gold Standard [ Time Frame: 1 year ]
    Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664634


Contacts
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Contact: Abigail Nellis (847) 467-8907 abigail.day@northwestern.edu
Contact: Cagla Kantarcigil cagla.kantarcigil@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Abigail Nellis         
Sponsors and Collaborators
Northwestern University
More Information
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Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04664634    
Other Study ID Numbers: STU00212981
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases