The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency

NCT01270204 | Completed

• 1 other identifier: 201018116
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of viscosity on swallowing efficiency.

Conditions

Dysphagia

Keywords

Dysphagia; Swallowing Problems; Dynamic Fluoroscopic Swallow Study; Aspiration; Regurgitation; Acid Reflux

Outcome Measures

Primary Outcomes (1)

• Swallowing amplitude as measured on digital accelerometry.

  Digital accelerometry is a non-invasive method of measuring swallowing efficiency. A surface sensor is taped to the skin over the region of the thyroid prominence. When the patient swallows, the sensors measures upward acceleration of the thyroid cartilage and a measurement of swallowing amplitude, a surrogate measure for swallowing efficiency, is obtained.

  Measurement is made at the time of patient participation.

Secondary Outcomes (1)

• To evaluate swallowing efficiency.

  Measurement is taken at the time of patient participation.

Study Arms (2)

Normal Volunteers

Patients older than 55 years of age with no history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.

Patients with Dysphagia

Patients older than 55 years of age with the following condition: Dysphagia (the sensation of swallowing difficulty), globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 dysphagic volunteers and 10 healthy volunteers

You may qualify if:

• Normal Volunteers:
• Older than 55 years of age
• No history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
• A normal self-administered dysphagia questionnaire (EAT-10 score of less than three)
• Patients with Dysphagia
• Older than 55 years of age
• Patients with the following condition: Dysphagia, globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.
• Patients willing to provide written informed consent for their participation in the study.

You may not qualify if:

• Patients unable to complete the administration of the full taste and viscosity protocol.
• Patients with profound dysphagia unable to safely consume the test solutions.
• Patients with known sensitivities or allergies to any of the test solutions.
• Patients who are prisoners.
• Patients have a history of diabetes.
• Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Otolaryngology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders

Study Officials

• Peter Belafsky, MD, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: January 5, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)