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Therapeutic Swallow Sensor

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04664634
Collaborator
(none)
50
Enrollment
1
Location
22.4
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Aug 14, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Percent agreement with Gold Standard [1 year]

      Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Northwestern University Evanston Illinois United States 60208

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shuai (Steve) Xu, Principal Investigator, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT04664634
    Other Study ID Numbers:
    • STU00212981
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jun 9, 2022