Normal Breathing and Swallowing in Healthy Volunteers

University of Florida

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Drug: Capsaicin; Device: Videofluoroscopic swallow study

Study type: Interventional

Funder types: Other

Identifiers

NCT03122145

IRB201700132 - A

Details and patient eligibility

About

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Full description

The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as ALS. One reason for this is the lack of normative data across various measures of swallowing and respiratory function. As a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. Therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. This will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment.

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Enrollment: 49 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Up to 120 individuals will be included in this study.
• Subjects will include both male and females who are aged between 18-100
• Healthy and with no major medical conditions.
• No specific gender or race will be excluded or targeted for participation in this study.

Exclusion criteria

• Adults who are pregnant
• Those with major medical conditions (i.e., swallowing impairment, brain injury) will be excluded from this study.
• Anyone with allergy to barium will be excluded from this study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Healthy Volunteers - Experiment 1

Experimental group

Description:

This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.

Treatment:

Device: Videofluoroscopic swallow study

Drug: Capsaicin

Healthy Volunteers - Experiment 2

Experimental group

Description:

This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo a instrumental swallowing evaluation (videofluoroscopy). The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.

Treatment:

Device: Videofluoroscopic swallow study