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Computerized Acoustic Swallowing Evaluation (CASE)

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ClinicalTrials.gov Identifier: NCT02925507
Recruitment Status : Withdrawn (Problems with biosensor not working properly and not functional for study)
First Posted : October 6, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
It is the purpose of this study to determine if a commercially available electronic stethoscope synchronized with an smart phone or iPad application can be used as an accurate and objective screening tool for measuring dysphagia. The investigators plan to do so in two phases; in Phase I the investigators will recruit normal subjects to establish normal swallowing patterns, as well as optimal sensor placement; and in Phase II the investigators will compare the recordings obtained by the electronic stethoscope with those obtained using videofluoroscopy.

Condition or disease Intervention/treatment
Deglutition Disorders Stroke Other: Swallowing Screen

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Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Computerized Acoustic Swallowing Evaluation in Patients With Stroke
Actual Study Start Date : October 2016
Primary Completion Date : June 19, 2017
Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Healthy Controls
Healthy patients with no neurologic impairments or disease
Other: Swallowing Screen
Patient will be ask to undergo a swallowing screen by study staff
Stroke Subjects
Patients with new onset stroke for ischemic, hemorrhagic or TIA
Other: Swallowing Screen
Patient will be ask to undergo a swallowing screen by study staff


Outcome Measures

Primary Outcome Measures :
  1. Acoustic Signal of Normal Swallowing Pattern [ Time Frame: 1 minute ]
    To establish the acoustic signals associated wtih a normal pattern of swallowing using an electronic stethoscope

  2. Acoustic Signal of Swallowing in the Stroke Population [ Time Frame: 1 minute ]
    To establish the acoustic signals associated with neurologic pattern of swallowing using an electronic stethoscope


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Phase 1: Normal Controls

Phase 2: Patients with new onset Ischemic, hemorrhagic or transient ischemic attack

Criteria

Inclusion Criteria:

  1. Admitted to CSMC for acute ischemic or hemorrhagic stroke, or TIA
  2. No history of head and/or neck cancer
  3. No tracheostomy or ventilator
  4. Able to follow simple one step commands
  5. 18 years of age or older

Exclusion Criteria:

  1. Not admitted to CSMC for acute ischemic or hemorrhagic stroke or TIA
  2. History of head and/or neck cancer
  3. Tracheostomy or ventilator
  4. Unable to follow simple one step commands
  5. Less than 18 years of age.
More Information

Publications:

Responsible Party: Pamela Roberts, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02925507     History of Changes
Other Study ID Numbers: Pro00044374
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will only be shared in the aggregate

Additional relevant MeSH terms:
Stroke
Deglutition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases