Computerized Acoustic Swallowing Evaluation

NCT02925507 | Withdrawn

• 1 other identifier: Pro00044374
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deglutition Disorders; Stroke

Outcome Measures

Primary Outcomes (2)

• Acoustic Signal of Normal Swallowing Pattern

  To establish the acoustic signals associated wtih a normal pattern of swallowing using an electronic stethoscope

  1 minute

• Acoustic Signal of Swallowing in the Stroke Population

  To establish the acoustic signals associated with neurologic pattern of swallowing using an electronic stethoscope

  1 minute

Study Arms (2)

Healthy Controls

Healthy patients with no neurologic impairments or disease

Other: Swallowing Screen

Stroke Subjects

Patients with new onset stroke for ischemic, hemorrhagic or TIA

Other: Swallowing Screen

Interventions

Swallowing Screen OTHER

Patient will be ask to undergo a swallowing screen by study staff

Healthy Controls; Stroke Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: Normal Controls Phase 2: Patients with new onset Ischemic, hemorrhagic or transient ischemic attack

You may qualify if:

• Admitted to CSMC for acute ischemic or hemorrhagic stroke, or TIA
• No history of head and/or neck cancer
• No tracheostomy or ventilator
• Able to follow simple one step commands
• years of age or older

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Related Publications (8)

• Armstrong JR, Mosher BD. Aspiration pneumonia after stroke: intervention and prevention. Neurohospitalist. 2011 Apr;1(2):85-93. doi: 10.1177/1941875210395775.

  PMID: 23983842 BACKGROUND

• Bhattacharyya N. The prevalence of dysphagia among adults in the United States. Otolaryngol Head Neck Surg. 2014 Nov;151(5):765-9. doi: 10.1177/0194599814549156. Epub 2014 Sep 5.

  PMID: 25193514 BACKGROUND

• Brogan E, Langdon C, Brookes K, Budgeon C, Blacker D. Dysphagia and factors associated with respiratory infections in the first week post stroke. Neuroepidemiology. 2014;43(2):140-4. doi: 10.1159/000366423. Epub 2014 Nov 5.

  PMID: 25402187 BACKGROUND

• Daniels SK, Brailey K, Priestly DH, Herrington LR, Weisberg LA, Foundas AL. Aspiration in patients with acute stroke. Arch Phys Med Rehabil. 1998 Jan;79(1):14-9. doi: 10.1016/s0003-9993(98)90200-3.

  PMID: 9440410 BACKGROUND

• Edmiaston J, Connor LT, Steger-May K, Ford AL. A simple bedside stroke dysphagia screen, validated against videofluoroscopy, detects dysphagia and aspiration with high sensitivity. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):712-6. doi: 10.1016/j.jstrokecerebrovasdis.2013.06.030. Epub 2013 Jul 30.

  PMID: 23910514 BACKGROUND

• Kendall KA, McKenzie S, Leonard RJ, Goncalves MI, Walker A. Timing of events in normal swallowing: a videofluoroscopic study. Dysphagia. 2000 Spring;15(2):74-83. doi: 10.1007/s004550010004.

  PMID: 10758189 BACKGROUND

• Leder SB, Bayar S, Sasaki CT, Salem RR. Fiberoptic endoscopic evaluation of swallowing in assessing aspiration after transhiatal esophagectomy. J Am Coll Surg. 2007 Oct;205(4):581-5. doi: 10.1016/j.jamcollsurg.2007.05.027.

  PMID: 17903733 BACKGROUND

• Trapl M, Enderle P, Nowotny M, Teuschl Y, Matz K, Dachenhausen A, Brainin M. Dysphagia bedside screening for acute-stroke patients: the Gugging Swallowing Screen. Stroke. 2007 Nov;38(11):2948-52. doi: 10.1161/STROKEAHA.107.483933. Epub 2007 Sep 20.

  PMID: 17885261 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: October 1, 2016
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share