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

NCT ID: NCT02183519

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

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.

Detailed Description

If the participant agrees to participate, the investigators will first test pulmonary (lung) function. Next, the investigators will test voluntary and reflex cough. After this first round of cough testing, the investigators will ask participants to cough long and hard during voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice box) with an endoscopic camera inserted through the nose. This test is done to see if there are any changes in the larynx that may influence cough.

Conditions

Cough; Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy older adults

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.

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: 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.

Voluntary cough test

Intervention Type: OTHER

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

Parkinson's disease

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.

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: 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.

Voluntary cough test

Intervention Type: OTHER

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

Interventions

Capsaicin

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.

Intervention Type: DRUG

Voluntary cough test

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen W. Hegland, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

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

Role: STUDY_DIRECTOR

University of Florida

Locations

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Dauer Hall, University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22144580 (View on PubMed)

Other Identifiers

IRB201400477

Identifier Type: -

Identifier Source: org_study_id