Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

NCT02183519 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB201400477
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to test cough function in individuals with Parkinson's disease and healthy older adults. Cough is a complex, defensive function which involves movement of the chest and lungs. The investigators want to compare the movement of the chest wall and the lungs during voluntary and reflex cough. The long-term goal of this research is to develop treatments for people with cough dysfunction. Cough dysfunction increases the risk for respiratory infections such as pneumonia. The results from this study will provide information to help researchers understand the difference between reflex and voluntary cough more fully.

Conditions

Cough; Parkinson's Disease

Keywords

Cough; Reflex; Voluntary; Healthy older adults; Parkinson's disease; Respiratory kinematics; Cueing

Outcome Measures

Primary Outcomes (1)

• Peak Expiratory Flow Rate

  Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.

  1-2 hours

Study Arms (2)

Healthy older adults

EXPERIMENTAL

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

Drug: Capsaicin; Other: Voluntary cough test

Parkinson's disease

EXPERIMENTAL

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

Drug: Capsaicin; Other: Voluntary cough test

Interventions

Capsaicin DRUG

For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of both the strength (airflow measures) of reflex, as well as cough sensitivity.

Healthy older adults; Parkinson's disease

Voluntary cough test OTHER

Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.

Healthy older adults; Parkinson's disease

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-85 years
• Ability to provide informed consent
• For participants with Parkinson's disease (PD):
• \- Diagnosis of PD (Hoehn \& Yahr stages II-IV) by a University of Florida Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain bank criteria.

You may not qualify if:

• Participants with PD:
• \- History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain tumor, etc)
• Healthy older adults:
• History of neurological disease including PD
• History of head and neck cancer
• History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease, asthma)
• History of smoking for more than 5 years at any one time (as this reduces the sensitivity to capsaicin)
• History of chest infection the last 5 weeks
• Failure of a screening test of pulmonary function (e.g. forced expiratory volume in one second/forced vital capacity\<75%)
• Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32611, United States

Location

Dauer Hall, University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Smith JA, Aliverti A, Quaranta M, McGuinness K, Kelsall A, Earis J, Calverley PM. Chest wall dynamics during voluntary and induced cough in healthy volunteers. J Physiol. 2012 Feb 1;590(3):563-74. doi: 10.1113/jphysiol.2011.213157. Epub 2011 Dec 5.

  PMID: 22144580 BACKGROUND

MeSH Terms

Conditions

Cough; Parkinson Disease

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Karen Hegland, PhD
• Organization: University of Florida Communicative Disorders

kwheeler@ufl.edu

352-273-3710

Study Officials

• Karen W. Hegland, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Alexandra E. Brandimore, M.A. CCC/SLP

  University of Florida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 1\) baseline respiratory maneuvers for calibration of the Respitrace system with spirometry 2) sequential voluntary cough (no cueing), 3) reflex cough sensitivity testing to establish the lowest concentration of capsaicin that elicits a two cough response (C2) (no cueing), 4) randomized production of sequential voluntary cough (3x) or reflex cough induced with C2 (3x) with cueing to 'cough long and hard' and 5) flexible laryngoscopy to assess age-related changes to the larynx that may impact cough function.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2017

Record last verified: 2017-02

Locations

US (2)