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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01270204
Other study ID # 201018116
Secondary ID
Status Completed
Phase N/A
First received December 16, 2010
Last updated May 25, 2017
Start date January 2011
Est. completion date November 2012

Study information

Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.

Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. We hypothesize that alterations in food taste (sweet, salty, etc…), viscosity, and temperature, will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture, and temperature on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

1. Patients unable to complete the administration of the full taste and viscosity protocol.

2. Patients with profound dysphagia unable to safely consume the test solutions.

3. Patients with known sensitivities or allergies to any of the test solutions.

4. Patients who are prisoners.

5. Patients have a history of diabetes.

6. Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States UC Davis Department of Otolaryngology Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To evaluate swallowing efficiency. Peak pharyngeal pressure, upper esophageal sphincter (UES) residual pressure, and UES relaxation time, all surrogate measure sof swallowing efficiency, will be measured using pharyngeal manometry. Measurement is taken at the time of patient participation.
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