Clinical trial NCT03122145: Normal Breathing and Swallowing in Healthy Volunteers
Official title: Establishing Normal Swallowing and Breathing Profiles in Healthy Adults Across the Age Span
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: healthy
volunteer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reflexive Cough Testing (With Urge-to-Cough)
timeFrame: Single assessment time period
measure: Duration of Laryngeal Vestibule Closure (dLVC)
timeFrame: Single Visit
measure: Laryngeal Vestibule Closure Reaction Time (LVCrt)
timeFrame: Single Visit
Secondary outcomes:
measure: Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)
timeFrame: Baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References: